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Related substance analysis method of terazosin hydrochloride tablets

A technology of terazosin hydrochloride tablets and related substances, which is applied in the field of analysis and detection of related substances of terazosin hydrochloride tablets, can solve problems such as no reports of terazosin hydrochloride tablets, and achieve qualified inspection and peak purity , high yield effect

Active Publication Date: 2016-07-13
南京易亨制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, there are no reports of other impurities (related substances) in terazosin hydrochloride tablets

Method used

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  • Related substance analysis method of terazosin hydrochloride tablets
  • Related substance analysis method of terazosin hydrochloride tablets
  • Related substance analysis method of terazosin hydrochloride tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Example 1: Preparation and structural confirmation of related substances

[0039] Get 10g of terazosin hydrochloride raw material and spread evenly in the petri dish, place in oven, 85 ℃ destroy 42 hours. Then, the high-temperature destruction sample was dissolved in methanol-water solution with a methanol volume percentage concentration of 80%, stirred for 20 minutes, filtered with a suction filter funnel, collected the filtrate, and concentrated under reduced pressure to obtain 6.2 g of a concentrate; then the concentrate was used Dissolve 8ml of methanol, mix the sample with 8g of normal-phase silica gel with a particle size of 100-200 mesh, evaporate the solvent, use 120g of normal-phase silica gel with a particle size of 200-300 mesh as separation silica gel for column chromatography, and use chloroform with a volume ratio of 7:2 -Isocratic elution with methanol mixed solvent, collect the 11th column volume eluate, concentrate under reduced pressure to obtain 4.8g ...

Embodiment 2

[0043] Embodiment 2: the preparation of related substance

[0044] Get 10g of terazosin hydrochloride raw material and spread evenly in the petri dish, place in oven, 80 ℃ destroy 48 hours. Then, the high-temperature destruction sample was dissolved in methanol-water solution with a concentration of 70% by volume of methanol, stirred for 20 minutes, filtered with a suction filter funnel, collected the filtrate, and concentrated under reduced pressure to obtain 6.1 g of concentrate; Dissolve 8ml of methanol, mix the sample with 8g of normal-phase silica gel with a particle size of 100-200 mesh, evaporate the solvent, use 120g of normal-phase silica gel with a particle size of 200-300 mesh as separation silica gel for column chromatography, and use chloroform with a volume ratio of 5:1 -Isocratic elution with methanol mixed solvent, collect the 14th column volume eluate, concentrate under reduced pressure to obtain 4.5 g of crude product; then dissolve the crude product with ace...

Embodiment 3

[0045] Embodiment 3: the preparation of related substance

[0046] Get 10g of terazosin hydrochloride raw material and spread evenly in the petri dish, place in oven, 90 ℃ destroy 36 hours. Then, the high-temperature damage sample was dissolved in methanol-water solution with a methanol volume percentage concentration of 90%, stirred for 20 minutes, filtered with a suction filter funnel, collected the filtrate, and concentrated under reduced pressure to obtain 6.4 g of concentrate; Dissolve 8ml of methanol, mix the sample with 8g of normal-phase silica gel with a particle size of 100-200 mesh, evaporate the solvent, use 120g of normal-phase silica gel with a particle size of 200-300 mesh as separation silica gel for column chromatography, and use chloroform with a volume ratio of 2:1 - Isocratic elution with methanol mixed solvent, collect the 8th column volume eluate, concentrate under reduced pressure to obtain 4.9 g of crude product; then dissolve the crude product with ace...

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Abstract

The invention discloses a related substance analysis method of terazosin hydrochloride tablets. A related substance is reported for the first time. A preparation method comprises the following steps: damaging a terazosin hydrochloride crude drug under the condition of 80 DEG C to 90 DEG C for 36 to 48 hours; dissolving the sample which is damaged at the high temperature into a methanol-water solution with the methanol volume percent concentration of 70 percent to 90 percent; stirring and filtering through suction; collecting filtrate, and decompressing and concentrating to obtain a concentrate; carrying out chromatographic separation on the concentrate with a normal-phase silica gel column, and carrying out gradient elution with a chloroform-methanol mixed solvent at the volume ratio of (5:1) to (2:1); collecting 8th to 14th column volume eluting solutions and concentrating to obtain a rough product; purifying the rough product with a reversed-phase silica gel column, wherein a fixed phase is octadecyl silane bonded silica gel and a mobile phase is acetonitrile-water with the acetonitrile volume percent concentration of 80 percent to 90 percent; carrying out gradient elution and collecting 7th to 11th column volume eluting solutions, and concentrating, freezing and drying. The preparation method is simple and feasible. The liquid-phase analysis method provided by the invention can be used for effectively separating the chromatographic peak of the related substance and the chromatographic peak of terazosin.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, relates to preparation stability research, in particular to a method for analyzing and detecting related substances of terazosin hydrochloride tablets. Background technique [0002] Terazosin hydrochloride (TZ) is a long-acting antihypertensive drug developed by Abbott Company in the 1980s, which can block peripheral postsynaptic α1-adrenergic receptors, thereby causing vasodilation, Decreased peripheral vascular resistance lowers blood pressure. This product has the advantages of minimal impact on cardiac output, does not cause reflex rapid heartbeat, does not reduce renal blood flow or glomerular filtration, etc. Due to the blockage of α1-adrenergic receptors, the bladder neck, prostate, and prostate capsule smooth muscle relax, and the urethral resistance, pressure, and bladder resistance decrease, thereby reducing urethral symptoms. Therefore, terazosin hydrochloride is also curren...

Claims

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Application Information

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IPC IPC(8): C07D405/12G01N30/02
CPCC07D405/12G01N30/02G01N2030/027
Inventor 赵明亮
Owner 南京易亨制药有限公司
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