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Method for determining related substances in acotiamide hydrochloride bulk drug and preparation thereof by using HPLC

A technology for acotiamide hydrochloride and related substances, which is applied in the field of pharmaceutical analysis, can solve problems that need to be improved, and achieve the effects of good separation, high precision, and strong specificity

Active Publication Date: 2017-10-03
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 preparation thereof by using HPLC
  • Method for determining related substances in acotiamide hydrochloride bulk drug and preparation thereof by using HPLC
  • Method for determining related substances in acotiamide hydrochloride bulk drug and preparation thereof by using 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 wer...

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, ...

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 ...

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Abstract

The invention discloses a method for determining the related substances in an acotiamide hydrochloride bulk drug and a preparation thereof by using HPLC, wherein the chromatographic conditions of the method comprise that the chromatographic column is an octyl silane bonded silica gel column, and the mobile phase is the mixed solution of a phosphate buffer liquid and a first organic solvent. According to the present invention, with the method, the related substances in the acotiamide hydrochloride bulk drug and the preparation thereof can be rapidly and efficiently separated under the same chromatographic conditions so as to effectively control the quality of the bulk drug and the preparation; and the detection method has advantages of strong specificity, high detection sensitivity, high precision, high accuracy, easy operation, and effective control of 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 Applications(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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