A process for the preparation of finerenone and intermediates thereof

Abstract

The present invention provides a novel, efficient and industrially advantageous process for the preparation of Finerenone of Formula I. The present invention also provides a process for preparation of Finerenone intermediates of Formula II and Formula V, and their use for the preparation of Finerenone of Formula I. wherein, R1 and R2 each independently selected from hydrogen, C1 to C6 substituted or unsubstituted alkyl, SO3Na or SO3K.

Description

[0001]A PROCESS FOR THE PREPARATION OF FINERENONE AND INTERMEDIATES THEREOF FIELD OF THE INVENTION: The present invention relates to novel, efficient and industrially advantageous process for the preparation of Finerenone of Formula-I. The present invention also relates to process for preparation of Finerenone intermediates of Formula-II, Formula-V and their use for the preparation of Finerenone of Formula-I. BACKGROUND OF THE INVENTION: Finerenone is chemically known as (4S)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8- dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxamide having the structure of Formula-I, [Formula I] Finerenone has been developed by Bayer Healthcare Pharmaceuticals Inc. and approved by United States Food and Drug Administration (USFDA) on July 09th , 2021 under proprietary name Kerendia® . Finerenone is a non-steroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). The US patent number US8436180 (herein after US‘180) first discloses Finerenone and its process by reacting 4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6- naphthyridine-3-carboxylic acid with ammonia in presence of 1,1'-carbonyldiimidazole, ethyl acetate and dimethylformamide. After completion of reaction, racemic Finerenone was obtained by preparative High Performance Liquid Chromatography (HPLC). Desired specific S-isomer of Finerenone was then obtained by chiral High Performance Liquid Chromatography (HPLC). The US patent publication number US20210163474 (herein after US ‘474) discloses process for preparation of Finerenone comprising reacting racemic Finerenone with (+)- O,O-dibenzoyl-D-tartaric acid in presence of ethanol followed by heating and cooling to obtain corresponding (+)-O,O-dibenzoyl-D-tartaric acid salt of Finerenone. Resulting (+)- O,O-dibenzoyl-D-tartaric acid salt of Finerenone was suspended in ethanol followed by addition of aqueous sodium phosphate solution to obtain crude Finerenone. Resulting crude Finerenone was purified using ethanol to obtain desired ‘S’ isomer of Finerenone. PCT publication number WO2023205164 (herein after WO ‘164) discloses process for preparation of Finerenone comprising reacting 4-(5-ethoxy-3-(1H-imidazole-1-carbonyl)- 2,8,-dimethyl-1,4-dihydro-1,6-naphthyridi-4yl)-3-methoxybenzonitrile with (+)-di-p- toluyl-D-tartaric acid in presence of acetone to obtain (S)-4-(4-cyano-2-methoxyphenyl)-5- ethoxy-2,8,-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxylic ditoluyl tartrate salt with 52.9% yield. Resulting salt was purified using mixture of water and acetic acid to obtain pure (S)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8,-dimethyl-l,4-dihydro-l,6- naphthyridine-3-carboxylic ditoluoyl tartrate salt having 25% yield. Resulting salt was treated with 2-methyltetrahydrofuran and water followed by addition of aqueous sodium bicarbonate solution to obtain (S)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy 2,8,-dimethyl- l,4-dihydro-l,6-naphthyridine-3-carboxylic acid. Resulting (S)-4-(4-cyano-2- methoxyphenyl)-5-ethoxy-2,8,-dimethyl-l,4-dihydro-l,6-naphthyridine-3- carboxylic acid was further treated with thionyl chloride in presence methylene dichloride followed by addition of aqueous ammonia to obtain crude Finerenone having 50 to 55% yield. Resulting crude Finerenone was purified using acetone to obtain pure ‘S’ isomer of Finerenone having 45 to 50% yield and 98% purity. Prior art process requires preparative HPLC, chiral HPLC or multiple purification methods to obtain a desired isomer of Finerenone. Therefore, there is a need to develop a novel intermediate of Finerenone which solves the problem of prior art. Present inventors have developed novel intermediate of Finerenone and its use for the preparation of Finerenone which offers advantages over the prior-art process in terms of high yield, high purity, which is suitable for large scale industrial production. OBJECT OF THE INVENTION: The main object of the present invention is to provides a novel, efficient and industrially advantageous process for the preparation of Finerenone of Formula-I. Another object of the present invention is to provides a process for preparation of Finerenone intermediates of Formula-II and Formula-V, and their use for the preparation of Finerenone of Formula-I. SUMMARY OF INVENTION: First aspect of the present invention is to provides a compound of Formula-II, [Formula II] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K or enantiomer or diastereomers thereof. Second aspect of the present invention is to provides a process for preparation of Finerenone of Formula-I, [Formula I] comprising the steps of: a) reacting compound of Formula-III or salt thereof, [Formula III] with compound of Formula-IV, [Formula IV] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K to obtain compound of formula-II, [Formula II] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K b) resolving compound of Formula-II to obtain compound of Formula-V; [Formula V] wherein, R1 and R2 each independently selected from hydrogen, C1 to C6 substituted or unsubstituted alkyl, SO3Na or SO3K and c) converting compound of Formula-V to Finerenone of Formula-I. Third aspect of the present invention is to provides a process for preparation of compound of formula-II, [Formula II] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K comprising reacting compound of Formula-III or salt thereof, with compound of Formula-IV, [Formula IV] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K to obtain compound of formula-II. Fourth aspect of the present invention is to provides a process for preparation of compound of Formula-V, [Formula V] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K comprising resolving compound of Formula-II, [Formula II] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K to obtain compound of Formula-V. Fifth aspect of the present invention is to provides a process for preparation of Finerenone of Formula-I, [Formula I] comprising converting compound of Formula-V, [Formula V] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K to Finerenone of Formula-I. DETAILED DESCRIPTION OF INVENTION: In order to provide a clear and consistent understanding of the terms used in the present specification, a number of definitions are provided below. Moreover, unless defined otherwise, all technical and scientific terms as used herein have the same meaning as understood by the person skilled in the art. The use of the word “a” or “an” when used in conjunction with the term “comprising” in the specification may not only mean “one”, but also encompasses the meaning of “one or more”, “at least one”, and “one or more than one”. Similarly, the word “another” may mean at least a second or more. As used in this specification the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “consisting” (and any form of consisting, such as “consists”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “include” and “includes”) or “containing” (and any form of containing, such as “contain” and “contains”), are inclusive or open-ended and do not exclude additional, unrecited elements or process steps. The invention will now be described in detail in connection with certain preferred embodiments, so that various aspects thereof may be fully understood and appreciated. The best methods and materials of performing the present invention are described here. The present invention provides a novel, efficient and industrially advantageous process for the preparation of Finerenone of Formula-I. According to first embodiment, the present invention provides a compound of Formula-II, [Formula II] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K or enantiomer or diastereomers thereof. In the first embodiment, compound of Formula-II can be compound of Formula-IIa, [Formula IIa] or compound of Formula-Va, [Formula Va]. According to second embodiment, the present invention provides a process for preparation of Finerenone of Formula-I, [Formula I] comprising the steps of: a) reacting compound of Formula-III or salt thereof, [Formula III] with compound of Formula-IV, [Formula IV] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K to obtain compound of formula-II, [Formula II] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K b) resolving compound of Formula-II to obtain compound of Formula-V; [Formula V] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K and c) converting compound of Formula-V to Finerenone of Formula-I. In the second embodiment of step a), reaction of compound of Formula-III with compound of Formula-IV can be carried out in presence of condensing agent, base and solvent. Alternatively, reaction of compound of Formula-III with compound of Formula-IV can be carried out in presence of chlorinating agent and solvent. In the second embodiment of step a), the condensing agent can be selected from the group consisting of 1,3-dicyclohexylcarbodiimide (DCC), isobutyl chloroformate, pivaloyl chloride, isovaleryl chloride, 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide hydrochloride (EDC.HCl), 1- cyclohexyl-3-morpholinoethylcarbodiimide, 1-cyclohexyl-3- (4-diethylaminocyclohexyl)carbodiimide, N,N′-carbonyldiimidazole or 2-chloro-1,3- dimethylimidazolinium chloride. In the second embodiment of step a), the base can be selected from the group consisting of organic base or inorganic base; inorganic bases selected from "alkali metal carbonates" such as sodium carbonate, potassium carbonate, lithium carbonate, cesium carbonate; "alkali metal bicarbonates" such as sodium bicarbonate, potassium bicarbonate, lithium bicarbonate, cesium bicarbonate; "alkali metal hydroxides" such as sodium hydroxide, potassium hydroxide, lithium hydroxide; "alkyl metals" such as n-butyl lithium; "metal hydrides" such as lithium hydride, sodium hydride, potassium hydride; "alkali metal phosphates" such as disodium hydrogen phosphate, dipotassium hydrogen phosphate; ammonia such as aqueous ammonia, ammonia gas, methanolic ammonia and "organic bases" selected from the group consisting of methyl amine, ethyl amine, diisopropyl amine, diisopropylethyl amine (DIPEA), diisobutylamine, triethylamine, tert-butyl amine, pyridine, 4-dimethylaminopyridine (DMAP), N-methyl morpholine (NMM), methyl pyridine (NMP), 1,8-diazabicyclo[5.4.0]undec-7-ene (DBU), 1,5-diazabicyclo[4.3.0] non5- ene (DBN), 1,4-diazabicyclo[2.2.2]octane (DABCO), imidazole, alkalimetal alkoxides" such as sodium methoxide, sodium ethoxide, potassium methoxide, potassium ethoxide, sodium tert-butoxide, potassium tert-butoxide; "alkali metal amides" such as sodium amide, potassium amide, lithium amide, lithiumdiisopropyl amide (LDA), sodium bis(trimethylsilyl)amide (NaHMDS), potassiumbis(trimethylsilyl)amide, lithium bis(trimethysilyl)amide (LiHMDS) or mixture(s) thereof. In the second embodiment of step a), the solvent can be selected from the group consisting of ketones such as acetone, methyl ethyl ketone, methyl isobutyl ketone, ethyl isobutyl ketone; alkyl acetates such as methyl acetate, ethyl acetate, n-propyl acetate, isopropyl acetate, n-butyl acetate or isobutyl acetate; ethers such as diethyl ether, n-propyl ether, diisopropyl ether, methyl tertiary butyl ether, tetrahydrofuran, 2-methyl tetrahydrofuran or dimethoxyethane; nitriles such as acetonitrile, propionitrile, butyronitrile or isobutyronitrile; halogenated aliphatic hydrocarbons such as dichloromethane, dichloroethane, chloroform or carbon tetrachloride; aromatic hydrocarbons such as benzene, toluene or xylene; polar aprotic solvent such as dimethylsulfoxide, N,N- dimethylformamide or N-methylpyrrolidone; water; or mixture(s) thereof. In the second embodiment of step a), the chlorinating agent can be selected from the group consisting of thionyl chloride, sulfuryl chloride, oxalyl chloride or mixture(s) thereof. In the second embodiment of step a), reaction of compound of Formula-III with compound of Formula-IV can be carried out at temperature of about 10°C to about 50°C for 2 hours to 8 hours. In the second embodiment of step b), compound of Formula-II can be resolved using resolving agent to obtain compound of Formula-V. In the second embodiment of step b), resolving agent can be selected from the group consisting of dibenzoyl-D-tartaric acid, dibenzoyl-L-tartaric acid, di-p-toluyl-D-tartaric acid, di-p-toluyl-L-tartaric acid, di-p-nitro-D-tartaric acid, di-p-nitro-L-tartaric acid, di-p- chloro-D-tartaric acid, di-p-chloro-L-tartaric acid, di-p-methoxy-D-tartaric acid, di-p- methoxy-L-tartaric acid, di-p-bromo-D-tartaric acid, di-p-bromo-L-tartaric acid, di-p- cyano-D-tartaric acid, di-p-cyano-L-tartaric acid. In the second embodiment of step b), compound of Formula-II can be resolved using resolving agent in presence of solvent selected from the group consisting of alcohol such as methanol, ethanol, n-propyl alcohol, isopropyl alcohol, n-butyl alcohol, isobutyl alcohol, secondary-butyl alcohol or tert-butyl alcohol; ketones such as acetone, methyl ethyl ketone, methyl isobutyl ketone, ethyl isobutyl ketone; alkyl acetates such as methyl acetate, ethyl acetate, n-propyl acetate, isopropyl acetate, n-butyl acetate or isobutyl acetate; ethers such as diethyl ether, n-propyl ether, diisopropyl ether, methyl tertiary butyl ether, tetrahydrofuran, 2-methyl tetrahydrofuran or dimethoxyethane; nitriles such as acetonitrile, propionitrile, butyronitrile or isobutyronitrile; halogenated aliphatic hydrocarbons such as dichloromethane, dichloroethane, chloroform or carbon tetrachloride; aromatic hydrocarbons such as benzene, toluene or xylene; polar aprotic solvent such as dimethylsulfoxide, N,N-dimethylformamide or N-methylpyrrolidone; water; or mixture(s) thereof. In the second embodiment of step b), resolution of compound of Formula-II can be carried out by reacting compound of Formula-II with resolving agent at 20°C to about 85°C for 30 minutes to 8 hours. Resulting mixture can be cooled to 20°C to 35°C followed by filtration. Resulting solid can be treated with base selected from the group consisting of organic base or inorganic base; inorganic base is selected from the group consisting of sodium hydroxide, potassium hydroxide, sodium carbonate, sodium bicarbonate or mixture(s) thereof; organic base is selected from group consisting of tertiary amines such as triethylamine, N,N-diisopropylethylamine (DIPEA) or mixture thereof to obtain a compound of Formula-V. In the second embodiment of step c), compound of Formula-V can be converted to Finerenone of Formula-I using ammonia, solvent and base. In the second embodiment of step c), ammonia can be aqueous ammonia, ammonia gas, alcoholic ammonia or bis(trimethylsilyl)amine. In the second embodiment of step c), base can selected from methyl amine, ethyl amine, diisopropyl amine, diisopropylethyl amine (DIPEA), diisobutylamine, triethylamine, tert.butyl amine, pyridine, 4- dimethylaminopyridine (DMAP), N-methyl morpholine (NMM), methyl pyridine (NMP), 1,8-diazabicyclo[5.4.0]undec-7-ene (DBU), 1,5- diazabicyclo[4.3.0] non5-ene (DBN), 1,4-diazabicyclo[2.2.2]octane (DABCO), imidazole, alkalimetal alkoxides" such as sodium methoxide, sodium ethoxide, potassium methoxide, potassium ethoxide, sodium tert-butoxide, potassium tert-butoxide; "alkali metal amides" such as sodium amide, potassium amide, lithium amide, lithiumdiisopropyl amide (LDA), sodium bis(trimethylsilyl)amide (NaHMDS), potassiumbis(trimethylsilyl)amide, lithium bis(trimethysilyl)amide (LiHMDS) and / or mixtures thereof. In the second embodiment of step c), The solvent can be selected from the group consisting of alcohol such as methanol, ethanol, n-propyl alcohol, isopropyl alcohol, n-butyl alcohol, isobutyl alcohol, secondary-butyl alcohol or tert-butyl alcohol; ketones such as acetone, methyl ethyl ketone, methyl isobutyl ketone, ethyl isobutyl ketone; alkyl acetates such as methyl acetate, ethyl acetate, n-propyl acetate, isopropyl acetate, n-butyl acetate or isobutyl acetate; ethers such as diethyl ether, n-propyl ether, diisopropyl ether, methyl tertiary butyl ether, tetrahydrofuran, 2-methyl tetrahydrofuran or dimethoxyethane; nitriles such as acetonitrile, propionitrile, butyronitrile or isobutyronitrile; halogenated aliphatic hydrocarbons such as dichloromethane, dichloroethane, chloroform or carbon tetrachloride; aromatic hydrocarbons such as benzene, toluene or xylene; polar aprotic solvent such as dimethylsulfoxide, N,N-dimethylformamide or N-methylpyrrolidone; water; or mixture(s) thereof. In the second embodiment of step c), compound of Formula-V can be converted to Finerenone of Formula-I by reacting compound of Formula-V with ammonia in presence of solvent and base at temperature of about 10°C to about 90°C for 1 hour to 24 hours. According to third embodiment, the present invention provides a process for preparation of compound of formula-II, [Formula II] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K comprising reacting compound of Formula-III or salt thereof, with compound of Formula-IV, [Formula IV] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K” to obtain compound of formula-II. In the third embodiment, reaction of compound of Formula-III with compound of Formula- IV can be carried out in presence of condensing agent, base and solvent. Alternatively, reaction of compound of Formula-III with compound of Formula-IV can be carried out in presence of chlorinating agent and solvent. In the third embodiment, the condensing agent can be selected from the group consisting of 1,3-dicyclohexylcarbodiimide (DCC), pivaloyl chloride, isovaleryl chloride, 1-ethyl-3-(3- dimethylaminopropyl)carbodiimide hydrochloride (EDC.HCl), 1- cyclohexyl-3- morpholinoethylcarbodiimide,1-cyclohexyl-3-(4-25 diethylaminocyclohexyl)carbodiimide, N,N′-carbonyldiimidazole, 2-chloro-1,3- dimethylimidazolinium chloride or isobutyl chloroformate. In the third embodiment, the base can be selected from the group consisting of organic base or inorganic base; inorganic bases selected from "alkali metal carbonates" such as sodium carbonate, potassium carbonate, lithium carbonate, cesium carbonate; "alkali metal bicarbonates" such as sodium bicarbonate, potassium bicarbonate, lithium bicarbonate, cesium bicarbonate; "alkali metal hydroxides" such as sodium hydroxide, potassium hydroxide, lithium hydroxide; "alkyl metals" such as n-butyl lithium; "metal hydrides" such as lithium hydride, sodium hydride, potassium hydride; "alkali metal phosphates" such as disodium hydrogen phosphate, dipotassium hydrogen phosphate; ammonia such as aqueous ammonia, ammonia gas, methanolic ammonia and "organic bases" selected from the group consisting of methyl amine, ethyl amine, diisopropyl amine, diisopropylethyl amine (DIPEA), diisobutylamine, triethylamine, tert-butyl amine, pyridine, 4- dimethylaminopyridine (DMAP), N-methyl morpholine (NMM), methyl pyridine (NMP), 1,8-diazabicyclo[5.4.0]undec-7-ene (DBU), 1,5-diazabicyclo[4.3.0] non5-ene (DBN), 1,4- diazabicyclo[2.2.2]octane (DABCO), imidazole, alkalimetal alkoxides" such as sodium methoxide, sodium ethoxide, potassium methoxide, potassium ethoxide, sodium tert- butoxide, potassium tert-butoxide; "alkali metal amides" such as sodium amide, potassium amide, lithium amide, lithiumdiisopropyl amide (LDA), sodium bis(trimethylsilyl)amide (NaHMDS), potassiumbis(trimethylsilyl)amide, lithium bis(trimethysilyl)amide (LiHMDS) or mixture(s) thereof. In the third embodiment, the solvent can be selected from the group consisting of ketones such as acetone, methyl ethyl ketone, methyl isobutyl ketone, ethyl isobutyl ketone; alkyl acetates such as methyl acetate, ethyl acetate, n-propyl acetate, isopropyl acetate, n-butyl acetate or isobutyl acetate; ethers such as diethyl ether, n-propyl ether, diisopropyl ether, methyl tertiary butyl ether, tetrahydrofuran, 2-methyl tetrahydrofuran or dimethoxyethane; nitriles such as acetonitrile, propionitrile, butyronitrile or isobutyronitrile; halogenated aliphatic hydrocarbons such as dichloromethane, dichloroethane, chloroform or carbon tetrachloride; aromatic hydrocarbons such as benzene, toluene or xylene; polar aprotic solvent such as dimethylsulfoxide, N,N-dimethylformamide or N-methylpyrrolidone; water; or mixture(s) thereof. In the third embodiment, the chlorinating agent can be selected from the group consisting of thionyl chloride, sulfuryl chloride, oxalyl chloride or mixture(s) thereof. In the third embodiment, reaction of compound of Formula-III with compound of Formula- IV can be carried out at temperature of about 10°C to about 50°C for 2 hours to 8 hours. According to fourth embodiment, the present invention provides a process for preparation of compound of Formula-V, [Formula V] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K comprising resolving compound of Formula-II, [Formula II] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K to obtain compound of Formula-V. In the fourth embodiment, compound of Formula-II can be resolved using resolving agent to obtain compound of Formula-V. In the fourth embodiment, resolving agent can be selected from the group consisting of dibenzoyl-D-tartaric acid, dibenzoyl-L-tartaric acid, di-p-toluyl-D-tartaric acid, di-p-toluyl- L-tartaric acid, di-p-nitro-D-tartaric acid, di-p-nitro-L-tartaric acid, di-p-chloro-D-tartaric acid, di-p-chloro-L-tartaric acid, di-p-methoxy-D-tartaric acid, di-p-methoxy-L-tartaric acid, di-p-bromo-D-tartaric acid, di-p-bromo-L-tartaric acid, di-p-cyano-D-tartaric acid, di- p-cyano-L-tartaric acid. In the fourth embodiment, compound of Formula-II can be resolved using resolving agent in presence of solvent selected from the group consisting of alcohol such as methanol, ethanol, n-propyl alcohol, isopropyl alcohol, n-butyl alcohol, isobutyl alcohol, secondary- butyl alcohol or tert-butyl alcohol; ketones such as acetone, methyl ethyl ketone, methyl isobutyl ketone, ethyl isobutyl ketone; alkyl acetates such as methyl acetate, ethyl acetate, n-propyl acetate, isopropyl acetate, n-butyl acetate or isobutyl acetate; ethers such as diethyl ether, n-propyl ether, diisopropyl ether, methyl tertiary butyl ether, tetrahydrofuran, 2-methyl tetrahydrofuran or dimethoxyethane; nitriles such as acetonitrile, propionitrile, butyronitrile or isobutyronitrile; halogenated aliphatic hydrocarbons such as dichloromethane, dichloroethane, chloroform or carbon tetrachloride; aromatic hydrocarbons such as benzene, toluene or xylene; polar aprotic solvent such as dimethylsulfoxide, N,N-dimethylformamide or N-methylpyrrolidone; water; or mixture(s) thereof. In the fourth embodiment, resolution of compound of Formula-II can be carried out by reacting compound of Formula-II with resolving agent at 20°C to about 85°C for 30 minutes to 8 hours. Resulting mixture can be cooled to 20°C to 35°C followed by filtration. Resulting solid can be treated with base selected from the group consisting of organic base or inorganic base; inorganic base is selected from the group consisting of sodium hydroxide, potassium hydroxide, sodium carbonate, sodium bicarbonate or mixture(s) thereof; organic base is selected from group consisting of tertiary amines such as triethylamine, N,N-diisopropylethylamine (DIPEA) or mixture thereof to obtain a compound of Formula-V. According to fifth embodiment, the present invention provides a process for preparation of Finerenone of Formula-I, [Formula I] comprising converting compound of Formula-V, [Formula V] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K to Finerenone of Formula-I. In the fifth embodiment, compound of Formula-V can be converted to Finerenone of Formula-I using ammonia, solvent and base. In the fifth embodiment, ammonia can be aqueous ammonia, ammonia gas, alcoholic ammonia or bis(trimethylsilyl)amine. In the fifth embodiment, base can selected from methyl amine, ethyl amine, diisopropyl amine, diisopropylethyl amine (DIPEA), diisobutylamine, triethylamine, tert.butyl amine, pyridine, 4- dimethylaminopyridine (DMAP), N-methyl morpholine (NMM), methyl pyridine (NMP), 1,8-diazabicyclo[5.4.0]undec-7-ene (DBU), 1,5-diazabicyclo[4.3.0] non5- ene (DBN), 1,4-diazabicyclo[2.2.2]octane (DABCO), imidazole, alkalimetal alkoxides" such as sodium methoxide, sodium ethoxide, potassium methoxide, potassium ethoxide, sodium tert.butoxide, potassium tert.butoxide; "alkali metal amides" such as sodium amide, potassium amide, lithium amide, lithiumdiisopropyl amide (LDA), sodium bis(trimethylsilyl)amide (NaHMDS), potassiumbis(trimethylsilyl)amide, lithium bis(trimethysilyl)amide (LiHMDS) and / or mixtures thereof. In the fifth embodiment, the solvent can be selected from the group consisting of alcohol such as methanol, ethanol, n-propyl alcohol, isopropyl alcohol, n-butyl alcohol, isobutyl alcohol, secondary-butyl alcohol or tert-butyl alcohol; ketones such as acetone, methyl ethyl ketone, methyl isobutyl ketone, ethyl isobutyl ketone; alkyl acetates such as methyl acetate, ethyl acetate, n-propyl acetate, isopropyl acetate, n-butyl acetate or isobutyl acetate; ethers such as diethyl ether, n-propyl ether, diisopropyl ether, methyl tertiary butyl ether, tetrahydrofuran, 2-methyl tetrahydrofuran or dimethoxyethane; nitriles such as acetonitrile, propionitrile, butyronitrile or isobutyronitrile; halogenated aliphatic hydrocarbons such as dichloromethane, dichloroethane, chloroform or carbon tetrachloride; aromatic hydrocarbons such as benzene, toluene or xylene; polar aprotic solvent such as dimethylsulfoxide, N,N-dimethylformamide or N-methylpyrrolidone; water; or mixture(s) thereof. In the fifth embodiment, compound of Formula-V can be converted to Finerenone of Formula-I by reacting compound of Formula-V with ammonia in presence of solvent and base at temperature of about 10°C to about 90°C for 1 hour to 24 hours. The compound of Formula-IIa or compound of Formula-Va according to present invention is having HPLC purity of greater than 98.0% by HPLC, preferably greater than 99.0% by HPLC. EXAMPLES: The following examples are illustrative of some of the embodiments of the present invention described herein. These examples should not be considered to limit the spirit or scope of the invention in any way. Example 01: Preparation of 2-cyanoethyl-2-[(4-cyano-2-methoxyphenyl)methylidene]- 3-oxobutanoate To a stirred mixture of 4-cyano-2-methoxybenzaldehyde (1.0 Kg) and 2-butanol (4.0 L), piperidine (0.0635 Kg) was added at 25°C to 30°C. Acetic acid (0.04475 Kg) was added to the resulting mixture at same temperature. 2-cyanoethyl 3-oxobutanoate (1.15 Kg) was slowly added to resulting mixture at 25°C to 30°C. Resulting mixture was stirred for 3 hours at same temperature. After completion of reaction, the resulting mixture was filtered, washed with 2-butanol (1.0 L) followed by drying under vacuum for 8 hours at 60°C to 70°C to obtain a title compound (1.68 Kg) having HPLC Purity of 99.1%. Example 02: Preparation of 2-cyanoethyl-4-(4-cyano-2-methoxyphenyl)-2,8-dimethyl- 5-oxo-1,4,5,6-tetrahydro-1,6-naphthyridine-3-carboxylate To a stirred mixture of 2-cyanoethyl-2-[(4-cyano-2-methoxyphenyl)methylidene]-3- oxobutanoate (1.0 Kg) and 2-butanol (10.0 L), 4-amino-2-hydroxy-5-methyl pyridine (0.415 Kg) was added at 25°C to 35°C. Resulting mixture was heated at 95°C to 100°C and stirred for 12 hours. The resulting mixture was cooled to 20°C to 25°C and stirred for 1 hour. Resulting mixture was filtered, washed with 2-butanol (1.0 L) followed by drying under vacuum for 8 hours at 65°C to 75°C to obtain a title compound (1.06 Kg) having HPLC Purity of 99.2% Example 03: Preparation of 2-cyanoethyl-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8- dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxylate To a stirred mixture of 2-cyanoethyl-4-(4-cyano-2-methoxyphenyl)-2,8-dimethyl-5-oxo- 1,4,5,6-tetrahydro-1,6-naphthyridine-3-carboxylate (1.0 Kg) and dimethyl formamide (1.90 L), triethyl orthoformate (1.1 Kg) followed by conc. sulphuric acid (0.06 Kg) was added slowly at 25°C to 35°C. The resulting mixture was heated at 105°C to 115°C and stirred for 3 hours. The resulting mixture was cooled to 45°C to 55°C and purified water (4.0 L) was added to mixture. The resulting mixture was cooled to 10°C to 20°C and stirred for 1 hour. The resulting mixture was filtered, washed with purified water (1.0 L) followed by drying under vacuum for 8 hours at 65°C 75°C to obtain a title compound (0.98 Kg) having HPLC purity of 99.4%. Example 04: Preparation of 4–(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4- dihydro-1,6-naphthyridine-3-carboxylic acid To a stirred mixture of 2-cyanoethyl-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl- 1,4-dihydro-1,6-naphthyridine-3-carboxylate (1.0 Kg) and tetrahydrofuran (3.0 L), purified water (1.9 L) was added at 25°C to 35°C. Resulting mixture was cooled to 0°C to 10°C and 48% aqueous caustic lye solution was added at 0°C to 10°C. Resulting mixture was stirred for 3 hours at 5°C to 10°C. Purified water (3.0 L) and toluene (1.0 L) was added to resulting mixture at 0°C to 10°C. Resulting mixture was allowed to separate aqueous and organic layers. Resulting aqueous layer was extracted with toluene (1.0 L). Conc. hydrochloric acid (0.4 Kg) was added to resulting aqueous layer at 0°C to 10°C. Resulting mixture was stirred for 1 hour at same temperature. Resulting mixture was filtered, washed with purified water (1.0 L) and dried under vacuum for 10 hours at 60°C to 65°C to obtain a title compound (0.9 Kg) having HPLC purity of 99.5%. Example 05: Preparation of 2,5-dioxopyrrolidin-1-yl-4–(4-cyano-2-methoxyphenyl)-5- ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxylate of Formula IIa To a stirred mixture of 4–(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro- 1,6-naphthyridine-3-carboxylic acid (5.0 g) and dichloromethane (15.0 mL), dimethyl amino pyridine (0.4 g) followed by triethyl amine (1.35 g) and N-hydroxy succinimide (1.52 g) was added at 25°C to 35°C. Solution of N,N’-dicyclohexylcarbodiimide (3.0 g) in dichloromethane (10.0 mL) was added to resulting mixture at 30°C to 40°C. Resulting mixture was stirred for 3.0 hours at same temperature. Purified water (10.0 ml) was added to resulting mixture and stirred for 15 minutes at same temperature. Resulting mixture was filtered, washed with dichloromethane (5.0 mL). Resulting filtrate was allowed to separate aqueous and organic layers. Obtained organic layer was washed with purified water (10.0 mL). Resulting aqueous layer was extracted with methylene chloride (5.0 mL). Combined organic layers were distilled under vacuum below 40°C. Methanol (15.0 mL) was added to distilled mass and cooled obtained mixture to 25°C to 30°C. Resulting mixture was stirred for 30.0 minutes at 25°C to 30°C. Resulting solid was filtered, washed with methanol (5.0 mL) and dried under vacuum for 8 hours at 55°C to 60°C to obtain a title compound (6.0 g) having HPLC purity of 99.2%. Example 06: Preparation of 2,5-dioxopyrrolidin-1-yl-(4S)–(4-cyano-2- methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxylate of Formula Va To a stirred mixture of 2,5-dioxopyrrolidin-1-yl-4–(4-cyano-2-methoxyphenyl)-5-ethoxy- 2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxylate of Formula IIa (1.0 Kg) and acetonitrile (10.0 L), di-p-toluyl-D-tartaric acid (0.81 Kg) was added at 25°C to 35°C. Resulting mixture was stirred for 30 minutes at same temperature. Resulting mixture was heated to 50°C to 55°C and stirred for 2 hours at same temperature. Resulting mixture was then cooled to 25°C to 30°C and stirred for 2 hours at same temperature. Resulting mixture was filtered, washed with acetonitrile (1.0 L) to obtain a solid. Dichloromethane (2.0 L) and purified water (2.0 L) was added to resulting solid at 25°C to 30°C. Resulting mixture was cooled to 10°C to 15°C. Aqueous sodium carbonate solution was added to resulting mixture at same temperature to adjust pH=9.5. Resulting mixture was stirred for 20 minutes at same temperature. Resulting mixture was allowed to separate aqueous and organic layers. Obtained aqueous layer was extracted with dichloromethane (1.0 L). Combined organic layers were distilled and methanol (1.5 L) was added to distilled mass at 50°C. Resulting mixture was stirred for 15.0 minutes at 50°C and further stirred for 30.0 minutes at 25°C to 30°C. Resulting mixture was then filtered, washed with methanol (0.5 L) and dried under vacuum for 8 hours at 60°C to 65°C to obtain a title compound (0.45 Kg) having HPLC purity of 99.8% and Chiral purity of 99.8%. Example 07: Preparation of Finerenone To a stirred mixture of 2,5-dioxopyrrolidin-1-yl-(4S)–(4-cyano-2-methoxyphenyl)-5- ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxylate of Formula Va (1.0 Kg) and dichloromethane (5.0 L), aqueous Ammonia (3.0 L) followed by purified water (2.0 L) and 1,8-Diazabicyclo[5.4.0]undec-7-ene (0.32 Kg) was added at 25°C to 30°C. Resulting mixture was stirred for 8.0 hours at 25°C to 30°C. Resulting mixture was allowed to separate aqueous and organic layers. Purified water (2.0 L) was added to the resulting organic layer at 25°C to 35°C. Conc. hydrochloric acid (0.24 L) was added to the resulting mixture at 25°C to 35°C and allowed mixture to separate aqueous and organic layers. The resulting organic layer was extracted with purified water (2.0 L). Finally organic layer was distilled under vacuum at below 50°C. Retarder (3.0 L) was added to distilled mass and resulting mixture was stirred for 30 minutes at 75°C to 80°C. Resulting mixture was cooled to 10°C to 15°C and stirred for 30 minutes. The resulting mixture was filtered, washed with retarder (1.0 L) and dried under vacuum for 8 hours at 55°C to 65°C to obtain a title compound (0.7 Kg) having HPLC purity of 99.5%. Example 08: Preparation of 2,5-dioxopyrrolidin-1-yl-4–(4-cyano-2-methoxyphenyl)-5- ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxylate of Formula IIa To a stirred mixture of 4–(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro- 1,6-naphthyridine-3-carboxylic acid (5.0 g) and dichloromethane (15.0 mL), followed by triethyl amine (1.35 g) and N-hydroxy succinimide (1.52 g) was added at 25°C to 35°C. Solution of N,N’-dicyclohexylcarbodiimide (3.0 g) in dichloromethane (10.0 mL) was added to resulting mixture at 30°C to 40°C. Resulting mixture was stirred for 3.0 hours at same temperature. Purified water (10.0 ml) was added to resulting mixture and stirred for 15 minutes at same temperature. Resulting mixture was filtered, washed with dichloromethane (5.0 mL). Resulting filtrate was allowed to separate aqueous and organic layers. Obtained organic layer was washed with purified water (10.0 mL). Resulting aqueous layer was extracted with methylene chloride (5.0 mL). Combined organic layers were distilled under vacuum below 40°C. Ethyl acetate (15.0 mL) was added to distilled mass and cooled obtained mixture to 25°C to 30°C. Resulting mixture was stirred for 30.0 minutes at 25°C to 30°C. Resulting solid was filtered, washed with methanol (5.0 mL) and dried under vacuum for 8 hours at 55°C to 60°C to obtain a title compound (6.0 g) having HPLC purity of 99.4%. Example 09: Preparation of 2,5-dioxopyrrolidin-1-yl-(4S)–(4-cyano-2- methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxylate of Formula Va To a stirred mixture of 2,5-dioxopyrrolidin-1-yl-4–(4-cyano-2-methoxyphenyl)-5-ethoxy- 2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxylate of Formula IIa (1.0 Kg) and acetonitrile (20.0 L), di-p-toluyl-D-tartaric acid (0.81 Kg) was added at 25°C to 35°C. Resulting mixture was stirred for 30 minutes at same temperature. Resulting mixture was heated to 50°C to 55°C and stirred for 2 hours at same temperature. Resulting mixture was then cooled to 25°C to 30°C and stirred for 2 hours at same temperature. Resulting mixture was filtered, washed with acetonitrile (1.0 L) to obtain a solid. Dichloromethane (2.0 L) and purified water (2.0 L) was added to resulting solid at 25°C to 30°C. Resulting mixture was cooled to 10°C to 15°C. Aqueous sodium carbonate solution was added to resulting mixture at same temperature to adjust pH=9.5. Resulting mixture was stirred for 20 minutes at same temperature. Resulting mixture was allowed to separate aqueous and organic layers. Obtained aqueous layer was extracted with dichloromethane (1.0 L). Combined organic layers were distilled and methanol (1.5 L) was added to distilled mass at 50°C. Resulting mixture was stirred for 15.0 minutes at 50°C and further stirred for 30.0 minutes at 25°C to 30°C. Resulting mixture was then filtered, washed with methanol (0.5 L) and dried under vacuum for 8 hours at 60°C to 65°C to obtain a title compound (0.46 Kg) having HPLC purity of 99.8% and Chiral purity of 99.9%. Example 10: Preparation of Finerenone To a stirred mixture of 2,5-dioxopyrrolidin-1-yl-(4S)–(4-cyano-2-methoxyphenyl)-5- ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxylate of Formula Va (1.0 Kg) and dichloromethane (5.0 L), aqueous Ammonia (3.0 L) followed by purified water (2.0 L) and 1,8-Diazabicyclo[5.4.0]undec-7-ene (0.32 Kg) was added at 25°C to 30°C. Resulting mixture was stirred for 8.0 hours at 25°C to 30°C. Obtained mixture was allowed to separate aqueous and organic layers. Purified water (2.0 L) was added to the resulting organic layer at 25°C to 35°C and stirred it. The resulting mixture was allowed to separate aqueous and organic layers. Distilled out dichloromethane under vacuum. Charged acetone (4.0 L) and oxalic acid dihydrate (0.265 Kg) to obtained mixture. Heated the resulting mixture at 55°C to 60°C. Stirred the resulting mixture for 25 to 30 min. at 55°C to 60°C. Cooled obtained mixture at 5°C to 10°C. Stirred for 30 minutes. The resulting mixture was filtered, washed with acetone (1.0 L). Added purified water (4.0L) to obtained wet cake. Added potassium hydroxide solution (20%) to resulting obtained mixture to adjusted pH 9 to 11. Stirred the resulting mixture for 1 hour at 20°C to 30°C. The resulting mixture was filtered, washed with purified water (2.0 L) and dried under vacuum for 8 hours at 55°C to 65°C to obtain a title compound (0.61 Kg) having HPLC purity of 99.8%.

Claims

We Claim:

1. A compound of Formula-II, Nwherein, R1and R2each hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K, or enantiomer or diastereomers thereof.

2. A compound of Formula-IIa, Nor compound of Formula-Va, N.

3. The compound as claimed in claim 2, wherein compound of Formula-IIa or Formula-Va has HPLC purity of greater than 98.0% by HPLC.

4. A process for preparation of Finerenone of Formula-I, N comprising the steps of:a) reacting compound of Formula-III or salt thereof, Nwith compound of Formula-IV, Owherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K to obtain compound of formula-II,Nwherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K b) resolving compound of Formula-II to obtain compound of Formula-V; and Nwherein, R1 and R2 each independently selected from hydrogen, C1 to C6 substituted or unsubstituted alkyl, SO3Na or SO3K c) converting compound of Formula-V to Finerenone of Formula-I.

5. A process for preparation of compound of formula-II, Nwherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3Kcomprising reacting compound of Formula-III or salt thereof, Nwith compound of Formula-IV, O Rwherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K to obtain compound of formula-II.

6. The process as claimed in claims 4 and 5, wherein reaction of compound of Formula-III or salt thereof with compound of Formula-IV is carried out using condensing agent selected from the group consisting of 1,3-dicyclohexylcarbodiimide (DCC), isobutyl chloroformate, pivaloyl chloride, isovaleryl chloride, 1-ethyl-3-(3- dimethylaminopropyl)carbodiimide hydrochloride (EDC.HCl), 1- cyclohexyl-3- morpholinoethylcarbodiimide, 1-cyclohexyl-3-(4-diethylaminocyclohexyl)carbodiimide, N,N′-carbonyldiimidazole or 2-chloro-1,3- dimethylimidazolinium chloride; base selected from the group consisting of organic base or inorganic base; inorganic bases selected from "alkali metal carbonates" such as sodium carbonate, potassium carbonate, lithium carbonate, cesium carbonate; "alkali metal bicarbonates" such as sodium bicarbonate, potassium bicarbonate, lithium bicarbonate, cesium bicarbonate; "alkali metal hydroxides" such as sodium hydroxide, potassium hydroxide, lithium hydroxide; "alkyl metals" such as n-butyl lithium; "metal hydrides" such as lithium hydride, sodiumhydride, potassium hydride; "alkali metal phosphates" such as disodium hydrogen phosphate, dipotassium hydrogen phosphate; ammonia such as aqueous ammonia, ammonia gas, methanolic ammonia and "organic bases" selected from the group consisting of methyl amine, ethyl amine, diisopropyl amine, diisopropylethyl amine (DIPEA), diisobutylamine, triethylamine, tert-butyl amine, pyridine, 4- dimethylaminopyridine (DMAP), N-methyl morpholine (NMM), methyl pyridine (NMP), 1,8-diazabicyclo[5.4.0]undec-7-ene (DBU), 1,5-diazabicyclo[4.3.0] non5-ene (DBN), 1,4- diazabicyclo[2.2.2]octane (DABCO), imidazole, alkalimetal alkoxides" such as sodium methoxide, sodium ethoxide, potassium methoxide, potassium ethoxide, sodium tert- butoxide, potassium tert-butoxide; "alkali metal amides" such as sodium amide, potassium amide, lithium amide, lithiumdiisopropyl amide (LDA), sodium bis(trimethylsilyl)amide (NaHMDS), potassiumbis(trimethylsilyl)amide, lithium bis(trimethysilyl)amide (LiHMDS) or mixture(s) thereof; and solvent selected from the group consisting of ketones such as acetone, methyl ethyl ketone, methyl isobutyl ketone, ethyl isobutyl ketone; alkyl acetates such as methyl acetate, ethyl acetate, n-propyl acetate, isopropyl acetate, n-butyl acetate or isobutyl acetate; ethers such as diethyl ether, n-propyl ether, diisopropyl ether, methyl tertiary butyl ether, tetrahydrofuran, 2-methyl tetrahydrofuran or dimethoxyethane; nitriles such as acetonitrile, propionitrile, butyronitrile or isobutyronitrile; halogenated aliphatic hydrocarbons such as dichloromethane, dichloroethane, chloroform or carbon tetrachloride; aromatic hydrocarbons such as benzene, toluene or xylene; polar aprotic solvent such as dimethylsulfoxide, N,N-dimethylformamide or N-methylpyrrolidone; water; or mixture(s) thereof at temperature of about 10°C to about 50°C.

7. A process for preparation of compound of Formula-V, N[Formula V] wherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K comprising resolving compound of Formula-II, Nwherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K to obtain compound of Formula-V.

8. The process as claimed in claims 4 and claim 7, wherein resolution of compound of Formula-II is carried out using resolving agent selected from the group consisting of dibenzoyl-D-tartaric acid, dibenzoyl-L-tartaric acid, di-p-toluyl-D-tartaric acid, di-p- toluyl-L-tartaric acid, di-p-nitro-D-tartaric acid, di-p-nitro-L-tartaric acid, di-p-chloro-D- tartaric acid, di-p-chloro-L-tartaric acid, di-p-methoxy-D-tartaric acid, di-p-methoxy-L- tartaric acid, di-p-bromo-D-tartaric acid, di-p-bromo-L-tartaric acid, di-p-cyano-D-tartaric acid, di-p-cyano-L-tartaric acid in presence of solvent selected from the group consisting of alcohol such as methanol, ethanol, n-propyl alcohol, isopropyl alcohol, n-butyl alcohol, isobutyl alcohol, secondary-butyl alcohol or tert-butyl alcohol; ketones such as acetone, methyl ethyl ketone, methyl isobutyl ketone, ethyl isobutyl ketone; alkyl acetates such as methyl acetate, ethyl acetate, n-propyl acetate, isopropyl acetate, n-butyl acetate or isobutyl acetate; ethers such as diethyl ether, n-propyl ether, diisopropyl ether, methyl tertiary butyl ether, tetrahydrofuran, 2-methyl tetrahydrofuran or dimethoxyethane; nitriles such as acetonitrile, propionitrile, butyronitrile or isobutyronitrile; halogenated aliphatic hydrocarbons such as dichloromethane, dichloroethane, chloroform or carbon tetrachloride; aromatic hydrocarbons such as benzene, toluene or xylene; polar aproticsolvent such as dimethylsulfoxide, N,N-dimethylformamide or N-methylpyrrolidone; water; or mixture(s) thereof at temperature of about 20°C to about 85°C.

9. A process for preparation of Finerenone of Formula-I, N[Formula I] comprising converting compound of Formula-V, Nwherein, R1and R2each independently selected from hydrogen, C1to C6substituted or unsubstituted alkyl, SO3Na or SO3K to Finerenone of Formula-I.

10. The process as claimed in claims 4 and 9, wherein conversion of compound of Formula-V to Finerenone of Formula-I is carried out using ammonia, solvent and base; wherein ammonia is aqueous ammonia, ammonia gas, alcoholic ammonia or bis(trimethylsilyl)amine; base is selected from methyl amine, ethyl amine, diisopropyl amine, diisopropylethyl amine (DIPEA), diisobutylamine, triethylamine, tert.butyl amine, pyridine, 4- dimethylaminopyridine (DMAP), N-methyl morpholine (NMM), methyl pyridine (NMP), 1,8-diazabicyclo[5.4.0]undec-7-ene (DBU), 1,5-diazabicyclo[4.3.0]non5-ene (DBN), 1,4-diazabicyclo[2.2.2]octane (DABCO), imidazole, alkalimetal alkoxides" such as sodium methoxide, sodium ethoxide, potassium methoxide, potassium ethoxide, sodium tert-butoxide, potassium tert-butoxide; "alkali metal amides" such as sodium amide, potassium amide, lithium amide, lithiumdiisopropyl amide (LDA), sodium bis(trimethylsilyl)amide (NaHMDS), potassiumbis(trimethylsilyl)amide, lithium bis(trimethysilyl)amide (LiHMDS) and / or mixtures thereof; and solvent is selected from the group consisting of alcohol such as methanol, ethanol, n-propyl alcohol, isopropyl alcohol, n-butyl alcohol, isobutyl alcohol, secondary-butyl alcohol or tert-butyl alcohol; ketones such as acetone, methyl ethyl ketone, methyl isobutyl ketone, ethyl isobutyl ketone; alkyl acetates such as methyl acetate, ethyl acetate, n-propyl acetate, isopropyl acetate, n-butyl acetate or isobutyl acetate; ethers such as diethyl ether, n-propyl ether, diisopropyl ether, methyl tertiary butyl ether, tetrahydrofuran, 2-methyl tetrahydrofuran or dimethoxyethane; nitriles such as acetonitrile, propionitrile, butyronitrile or isobutyronitrile; halogenated aliphatic hydrocarbons such as dichloromethane, dichloroethane, chloroform or carbon tetrachloride; aromatic hydrocarbons such as benzene, toluene or xylene; polar aprotic solvent such as dimethylsulfoxide, N,N- dimethylformamide or N-methylpyrrolidone; water; or mixture(s) thereof at temperature of about 10°C to about 90°C.

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