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Method for separating and determining silodosin and optical isomer thereof by virtue of liquid chromatography

A technique of optical isomers and liquid chromatography, applied in the field of silodosin determination, to achieve the effect of accurate separation

Inactive Publication Date: 2019-04-05
ANHUI QINGYUN PHARMA & CHEM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The separation of optical isomers of compounds containing chiral carbon atoms has always been a difficult point in the quality control of chiral drugs. Therefore, the separation and determination of silodosin and its optical isomers is realistic in the quality control of silodosin Significance, but there is no report about the determination of silodosin optical isomers in the prior art

Method used

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  • Method for separating and determining silodosin and optical isomer thereof by virtue of liquid chromatography
  • Method for separating and determining silodosin and optical isomer thereof by virtue of liquid chromatography

Examples

Experimental program
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Effect test

Embodiment 1

[0030] A method for liquid chromatography separation and determination of silodosin and optical isomers thereof, said method comprising the steps of:

[0031] S1. Prepare the system suitability test solution: mix the silodosin racemate and the silodosin sample, add absolute ethanol, and shake well to obtain the system suitability test solution;

[0032] S2, preparation of reference substance solution: add absolute ethanol to the silodosin reference substance, shake well to obtain the reference substance solution;

[0033] S3, preparing the test solution: add absolute ethanol to the silodosin test product, shake well to obtain the test solution;

[0034] S4. Chromatographic determination: take the system suitability solution, inject it into the liquid chromatograph, and record the chromatogram Figure I Get reference substance solution, inject liquid chromatograph, adjust detection sensitivity; Get need testing solution and reference substance solution, inject liquid chromatogr...

Embodiment 2

[0036] A method for liquid chromatography separation and determination of silodosin and optical isomers thereof, said method comprising the steps of:

[0037] S1. Prepare the system suitability test solution: mix the silodosin racemate and the silodosin sample, add absolute ethanol, and shake well to obtain the system suitability test solution;

[0038] S2, preparation of reference substance solution: add absolute ethanol to the silodosin reference substance, shake well to obtain the reference substance solution;

[0039] S3, preparing the test solution: add absolute ethanol to the silodosin test product, shake well to obtain the test solution;

[0040] S4. Chromatographic determination: take the system suitability solution, inject it into the liquid chromatograph, and record the chromatogram Figure I Get reference substance solution, inject liquid chromatograph, adjust detection sensitivity; Get need testing solution and reference substance solution, inject liquid chromatogr...

Embodiment 3

[0044] A method for liquid chromatography separation and determination of silodosin and optical isomers thereof, said method comprising the steps of:

[0045] S1. Prepare the system suitability test solution: mix the silodosin racemate and the silodosin sample, add absolute ethanol, and shake well to obtain the system suitability test solution;

[0046] S2, preparation of reference substance solution: add absolute ethanol to the silodosin reference substance, shake well to obtain the reference substance solution;

[0047] S3, preparing the test solution: add absolute ethanol to the silodosin test product, shake well to obtain the test solution;

[0048] S4. Chromatographic determination: take the system suitability solution, inject it into the liquid chromatograph, and record the chromatogram Figure I Get reference substance solution, inject liquid chromatograph, adjust detection sensitivity; Get need testing solution and reference substance solution, inject liquid chromatogr...

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Abstract

The invention discloses a method for separating and determining silodosin and an optical isomer thereof by virtue of liquid chromatography. The method comprises the following steps: preparing system suitability test solution; preparing reference solution; preparing test solution; and performing chromatography, namely taking system suitability solution, injecting into a liquid chromatograph, and recording a chromatogram map I; taking the reference solution, injecting into the liquid chromatograph, and regulating detection sensitivity; and taking the test solution and the reference solution, respectively injecting into the liquid chromatograph, recording chromatogram maps II and III, and analyzing and calculating according to the chromatogram maps I, II and III. The method disclosed by the invention can simply, rapidly and accurately separate and detect the silodosin and the optical isomer thereof.

Description

technical field [0001] The invention relates to the technical field of silodosin determination, in particular to a method for the separation and determination of silodosin and its optical isomers by liquid chromatography. Background technique [0002] Silodosin is a drug for the treatment of benign prostatic hyperplasia, developed and marketed by a Japanese company, with a molecular formula of C 25 h 32 f 3 N 3 o 4 , the structure type belongs to phenalkamine compounds, and its chemical name is: (R)-(-)-1-(3-hydroxypropyl)-5-[2-[2-[2-(2,2,2 -trifluoroethoxy)phenoxy]ethylamino]propyl]-7-carbamoyl indoline, i.e. silodosin is the active ingredient. [0003] The silodosin molecule contains one chiral carbon atom, and optical isomers with different stereo configurations will be produced simultaneously during compound synthesis. For the optical isomers of silodosin, during the production of silodosin Quality control is required. The separation of optical isomers of compound...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 黄欢黄庆国赵东伟
Owner ANHUI QINGYUN PHARMA & CHEM
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