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Method for measuring content of 2-chloro-1-methylpyridinium iodide in Vilazodone hydrochloride by separating with liquid chromatography

A technology of vilazodone hydrochloride and methyl pyridinium, applied in the field of analytical chemistry, can solve problems such as affecting the purity and quality of drugs, and achieve the effects of quality controllability and safety improvement

Active Publication Date: 2016-10-12
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During the process, the purity and quality of the drug may be affected due to incomplete removal of 2-chloro-1-methylpyridinium iodide, which may lead to the safety of clinical medication

Method used

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  • Method for measuring content of 2-chloro-1-methylpyridinium iodide in Vilazodone hydrochloride by separating with liquid chromatography
  • Method for measuring content of 2-chloro-1-methylpyridinium iodide in Vilazodone hydrochloride by separating with liquid chromatography
  • Method for measuring content of 2-chloro-1-methylpyridinium iodide in Vilazodone hydrochloride by separating with liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Instruments and Conditions

[0040] High performance liquid chromatography: Shimadzu: LC-20AT, CBM-20A, SIL-20AC, SPD-M20A, CTO-10ASvp;

[0041] Chromatographic column: C18 (Kromasil, 250×4.6mm, 5μm)

[0042] Mobile phase: A: 50mmol / L sodium perchlorate (pH 3.0)

[0043] B: Acetonitrile

[0044] Flow rate: 1.0mL / min

[0045] Detection wavelength: 275nm

[0046] Column temperature: 30°C

[0047] Injection volume: 10μL

[0048] Elution gradient:

[0049] time (min)

Mobile phase A (%)

Mobile phase B (%)

0

97

3

5

97

3

6

30

70

23

30

70

24

97

3

35

97

3

[0050] Experimental procedure

[0051] Take an appropriate amount of vilazodone hydrochloride sample, dissolve the sample with mobile phase, and prepare a solution containing 0.5 mg of vilazodone hydrochloride per 1 mL; take vilazodone hydrochloride related substances and 2-chloro-1-methylpyridinium iodide An appropriate amo...

Embodiment 2

[0053] Instruments and Conditions

[0054] High performance liquid chromatography: Shimadzu: LC-20AT, CBM-20A, SIL-20AC, SPD-M20A, CTO-10ASvp;

[0055] Chromatographic column: C18 (Kromasil, 250×4.6mm, 5μm)

[0056] Mobile phase: A: 50mmol / L sodium perchlorate (pH 3.0)

[0057] B: Acetonitrile

[0058] Flow rate: 1.0mL / min

[0059] Detection wavelength: 275nm

[0060] Column temperature: 30°C

[0061] Injection volume: 10μL

[0062] Elution gradient:

[0063] time (min)

Mobile phase A (%)

Mobile phase B (%)

0

99

1

5

99

1

6

30

70

23

30

70

24

99

1

35

99

1

[0064] Experimental procedure

[0065] Take an appropriate amount of vilazodone hydrochloride sample, dissolve the sample with mobile phase, and prepare a solution containing 0.5 mg of vilazodone hydrochloride per 1 mL; take vilazodone hydrochloride related substances and 2-chloro-1-methylpyridinium iodide An appropriate amoun...

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Abstract

The invention belongs to the field of analytical chemistry and discloses a method for detecting 2-chloro-1-methylpyridinium iodide in Vilazodone hydrochloride by separating with a liquid chromatography. According to the method disclosed by the invention, the content of the 2-chloro-1-methylpyridinium iodide is calculated with an external standard method by adopting a chromatographic column with octadecyl silane-bonded silica gel as filler and taking a certain proportion of buffer salt solution-organic phase as a flowing phase. The method disclosed by the invention is strong in specificity, high in accuracy, favorable in reproducibility and simple and convenient to operate, can be used for qualitatively or quantitatively detecting the 2-chloro-1-methylpyridinium iodide in the Vilazodone hydrochloride, and ensures the quality of the Vilazodone hydrochloride, thereby improving the safety of clinical medication.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, in particular to a method for separating and measuring 2-chloro-1-methylpyridinium iodide in vilazodone hydrochloride by liquid chromatography. Background technique [0002] Vilazodone hydrochloride is a new type of antidepressant drug, which is the first indolealkylamine drug for the treatment of major depression in adults. The chemical name of vilazodone hydrochloride is 5-{4-[4-(5-cyano-3-indolyl)butyl]-1-piperazinyl}benzofuran-2-carboxamide hydrochloride, Molecular formula is C 26 h 27 N 5 o 2 • HCl. 2-Chloro-1-methylpyridinium iodide (CMPI) is a catalyst commonly used in the process of drug synthesis, which is irritating to human eyes, respiratory tract and skin; it may be damaged due to incomplete removal during drug synthesis. Affect the purity and quality of drugs, triggering the safety of clinical medication. The molecular formula of 2-chloro-1-methylpyridinium iodide is C 6 h...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 贾少华王宇杰刘秋叶
Owner BEIJING VENTUREPHARM BIOTECH
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