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Method for separating and determining vilazodone hydrochloride raw materials and preparations thereof by liquid chromatography

A technology for vilazodone hydrochloride and its determination method, which is applied in the field of separation and determination of vilazodone hydrochloride and its related substances by liquid chromatography, can solve the problems of not knowing the effect of the net result, and achieve the effect of ensuring quality

Active Publication Date: 2014-01-01
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] The mechanism of vilazodone hydrochloride's antidepressant effect is not fully understood, but it is considered to be related to its increased reuptake serotonergic activity in the CNS by selectively inhibiting serotonin, which is also a serotonergic 5-HT1A receptor. Partial agonists of the body, however, the net effect on serotonin transmission and its role in the antidepressant effect of vilazodone, clinically used in the treatment of major depressive disorder, is unknown

Method used

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  • Method for separating and determining vilazodone hydrochloride raw materials and preparations thereof by liquid chromatography
  • Method for separating and determining vilazodone hydrochloride raw materials and preparations thereof by liquid chromatography
  • Method for separating and determining vilazodone hydrochloride raw materials and preparations thereof by liquid chromatography

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Experimental program
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Effect test

Embodiment 1

[0035] Instruments and Conditions

[0036] High performance liquid chromatography: Shimadzu: LC-10ATvp, SPD-M10Avp;

[0037] Column: C 18 (Agela, 250 × 4.6 mm, 5 μm)

[0038] Mobile phase: A phase: 0.1% trifluoroacetic acid aqueous solution (pH3.0), B phase: acetonitrile, using gradient elution;

[0039] T(min) 0 15 17 30 35 45 B% 30 30 60 65 30 30

[0040] Flow rate: 1.0mL / min

[0041] Detection wavelength: 240nm

[0042] Column temperature: 25°C

[0043] Injection volume: 10μL

[0044] Experimental procedure

[0045] Take about 25mg of vilazodone hydrochloride and its intermediates respectively, put them in a 50mL measuring bottle, add methanol to dissolve and dilute to the mark, shake well, and take an appropriate amount of each to prepare a mixed sample solution.

[0046] Take reagent blank solution and mixed sample solution respectively, carry out high performance liquid chromatography analysis according to the above conditions, recor...

Embodiment 2

[0049] Instruments and Conditions

[0050] High performance liquid chromatography: Shimadzu: LC-10ATvp, SPD-M10Avp;

[0051] Column: C 18 (Agela, 250 × 4.6 mm, 5 μm)

[0052] Mobile phase: A phase: 0.1% trifluoroacetic acid aqueous solution (pH3.0), B phase: acetonitrile, using gradient elution;

[0053] T(min) 0 15 17 30 35 45 B% 30 30 60 65 30 30

[0054] Flow rate: 1.0mL / min

[0055] Detection wavelength: 240nm

[0056] Column temperature: 20°C

[0057] Injection volume: 10μL

[0058] Experimental procedure

[0059] Take about 25 mg of vilazodone hydrochloride raw material, put it in a 50 mL measuring bottle, add methanol to dissolve and dilute to the mark, shake well, and use it as the test solution.

[0060] Get need testing solution, carry out high performance liquid chromatography analysis by above-mentioned condition, record chromatogram, the result sees image 3 .

[0061] image 3 The chromatographic peak whose retention time ...

Embodiment 3

[0063] Instruments and Conditions

[0064] Column: C 18 (Agela, 250 × 4.6 mm, 5 μm)

[0065]Mobile phase: A phase: 0.1% trifluoroacetic acid aqueous solution (pH3.0), B phase: acetonitrile, using gradient elution;

[0066] T(min) 0 15 35 55 60 70 B% 30 30 60 65 30 30

[0067] Flow rate: 1.0mL / min

[0068] Detection wavelength: 240nm

[0069] Column temperature: 25°C

[0070] Injection volume: 10μL

[0071] Experimental procedure

[0072] Take an appropriate amount of vilazodone hydrochloride tablets, approximately equivalent to 12.5mg of vilazodone hydrochloride, put it in a 25mL measuring bottle, add mobile phase to ultrasonic treatment to dissolve, and dilute to the mark with methanol, shake well, filter, and take the subsequent filtrate as the supply Test solution.

[0073] Get the test solution, carry out high performance liquid chromatography analysis according to the above conditions, record the chromatogram, and carry out the blank ...

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Abstract

The invention belongs to the field of analysis chemistry, and specifically relates to a method for separating and determining vilazodone hydrochloride raw materials and the preparation thereof by liquid chromatography. According to the method, a chromatographic column with ctadecylsilane bonded silica gel as the filling material is employed, the mobile phase is a mixture of an acid aqueous solution and an organic phase with a certain ratio, and thus the contents of vilazodone hydrochloride and other related substances, so that the quality of vilazodone hydrochloride and preparations containing vilazodone hydrochloride are effectively controlled. The method is strong in specificity, high in accuracy and simple to operate.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, in particular to a method for separating and measuring vilazodone hydrochloride and its related substances by liquid chromatography. Background technique [0002] The mechanism of vilazodone hydrochloride's antidepressant effect is not fully understood, but it is considered to be related to its increased reuptake serotonergic activity in the CNS by selectively inhibiting serotonin, which is also a serotonergic 5-HT1A receptor. Partial agonists of the body, however, do not know the net effect on serotonin transmission and its role in the antidepressant effect of vilazodone, clinically used in the treatment of major depressive disorder. The chemical name of vilazodone hydrochloride is 5-{4-[4-(5-Cyano-1 H -indol-3-yl)-butyl]-piperazin-1-yl}-benzofuran-2-carboxylic acid amide, the molecular formula is C 26 h 28 ClN 5 o 2 . The structural formula of vilazodone hydrochloride is: [0003] ...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/02
Inventor 刘秋叶方灿良郭夏
Owner BEIJING VENTUREPHARM BIOTECH
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