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Method for determining related substances in acotiamide hydrochloride bulk drug and its preparations by HPLC

A technology for acotiamide hydrochloride and related substances, applied in the field of drug analysis, can solve problems to be improved, etc., and achieve the effects of good separation, strong operability and high detection sensitivity

Active Publication Date: 2021-05-28
WATERSTONE PHARMA WUHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the current method for analyzing related substances in acotiamide hydrochloride bulk drug and its preparations still needs to be improved

Method used

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  • Method for determining related substances in acotiamide hydrochloride bulk drug and its preparations by HPLC
  • Method for determining related substances in acotiamide hydrochloride bulk drug and its preparations by HPLC
  • Method for determining related substances in acotiamide hydrochloride bulk drug and its preparations by HPLC

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Instrument: Agilent 1260 High Performance Liquid Chromatograph, 1260Infinity Diode Array Detector

[0057] Chromatographic column: Hypersil BDS C8 (250*4.6mm, 5μm)

[0058] Mobile phase A: 0.02mol / L potassium dihydrogen phosphate buffer solution (containing 0.2 volume% triethylamine, adjust pH to 6.0 with concentrated phosphoric acid)

[0059] Mobile Phase B: Acetonitrile

[0060] See the table below for gradient elution:

[0061] time / min Phosphate buffer / % The first organic solvent / % 0 85 15 20 65 35 25 50 50 30 50 50 30.01 85 15 35 85 15

[0062] Flow rate: 1.0mL / min

[0063] Detection wavelength: 220nm

[0064] Column temperature: 30°C

[0065] Injection volume: 10μL

[0066] Solvent: acetonitrile-water (30:70)

[0067] Run time: 35 minutes

[0068] 1. Determination of chromatographic conditions

[0069] Acotiamide hydrochloride and its impurity 1 to impurity 7 were scanned by ultraviolet spectrum between...

Embodiment 2

[0086] Instrument: Agilent 1260 High Performance Liquid Chromatograph, 1260Infinity Diode Array Detector

[0087] Chromatographic column: Hypersil BDS C8 (250*4.6mm, 5μm)

[0088] Mobile phase A: 0.02mol / L potassium dihydrogen phosphate buffer solution (containing 0.2 volume% triethylamine, adjust pH to 6.0 with concentrated phosphoric acid)

[0089] Mobile Phase B: Acetonitrile

[0090] See the table below for gradient elution:

[0091] time / min Phosphate buffer / % The first organic solvent / % 0 85 15 20 65 35 25 50 50 30 50 50 30.01 85 15 35 85 15

[0092] Flow rate: 1.0mL / min

[0093] Detection wavelength: 220nm

[0094] Column temperature: 30°C

[0095] Injection volume: 10μL

[0096] Solvent: acetonitrile-water (30:70)

[0097] Run time: 35 minutes

[0098] Experimental steps:

[0099] The test solution: Accurately weigh about 25 mg of acotiamide hydrochloride crude drug, put it in a 50 mL measuring bottle, add a...

Embodiment 3

[0104] Instrument: Agilent 1260 High Performance Liquid Chromatograph, 1260Infinity Diode Array Detector

[0105] Chromatographic column: Hypersil BDS C8 (250*4.6mm, 5μm)

[0106] Mobile phase A: 0.02mol / L potassium dihydrogen phosphate buffer solution (containing 0.2 volume% triethylamine, adjust pH to 6.0 with concentrated phosphoric acid)

[0107] Mobile Phase B: Acetonitrile

[0108] See the table below for gradient elution:

[0109] time / min Phosphate buffer / % The first organic solvent / % 0 85 15 20 65 35 25 50 50 30 50 50 30.01 85 15 35 85 15

[0110] Flow rate: 1.0mL / min

[0111] Detection wavelength: 220nm

[0112] Column temperature: 30°C

[0113] Injection volume: 10μL

[0114] Solvent: acetonitrile-water (30:70)

[0115] Run time: 35 minutes

[0116] Experimental steps:

[0117] Need testing solution: Accurately weigh an appropriate amount of acotiamide hydrochloride tablet fine powder (equivalent to about 2...

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Abstract

The invention discloses a method for determining acotiamide hydrochloride bulk drug and related substances in its preparation by HPLC. The chromatographic conditions of the method are as follows: a chromatographic column is an octanylsilane-bonded silica gel column; the mobile phase is a phosphate buffer solution mixed solution with the first organic solvent. By adopting the method, the acotiamide hydrochloride crude drug and the related substances in the preparation can be rapidly and efficiently separated under the same chromatographic condition, and the quality of the crude drug and the preparation can be effectively controlled. The detection method has strong specificity, high detection sensitivity, high precision, strong accuracy, convenient operation, and can effectively control product quality.

Description

technical field [0001] The invention belongs to the technical field of drug analysis. Specifically, the invention relates to a method for determining related substances in acotiamide hydrochloride crude drug and its preparation by using HPLC (high performance liquid chromatography). Background technique [0002] Acotiamide hydrochloride (Acotiamide hydrochloride hydrate) is the world's first functional dyspepsia (Functional dyspepsia, FD) treatment drug, a new type of drug jointly developed by Japan Astellas Pharmaceutical Co. The muscarinic M1 and M2 receptor blockers that promote gastric motility mainly work through the mechanism of inhibiting acetylcholinesterase in the digestive tract, which can promote gastric motility, improve gastric accommodation disorders, and enhance gastric fundus expansion. [0003] Acotiamide hydrochloride oral tablet (trade name Acofide, specification is 100mg), was approved in Japan on June 6, 2013 for the treatment of functional dyspepsia, cl...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 付美玲高宏平钱丽娜杨科
Owner WATERSTONE PHARMA WUHAN
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