Detection method and application of silodosin enantiomer

An enantiomer and detection method technology, applied in the field of medicine, can solve the problems of high requirements for high performance liquid chromatography, affecting the purity of silodosin, long washing time, etc., and achieves good sensitivity, good durability, The effect of a short rinse time

Active Publication Date: 2019-10-25
北京华氏康源医药科技有限公司
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  • Abstract
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  • Claims
  • Application Information

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Problems solved by technology

[0002] The chemical name of silodosin is: 1-(3-hydroxypropyl)-5-[(2R)-2-({2-(2,2,2-trifluoroethoxy)phenoxy]ethyl base}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide, which contains a chiral carbon, so in silodosin there will inevitably be a pair of silodosin The enantiomer is: 1-(3-hydroxypropyl)-5-[(2S)-2-({2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino )propyl]-2,3-dihydro-1H-indole-7-carboxamide, and the existence of silodosin enantio

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  • Detection method and application of silodosin enantiomer
  • Detection method and application of silodosin enantiomer

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Embodiment 1

[0050] A method for detecting silodosin enantiomers, comprising:

[0051] Step S1, dissolve an appropriate amount of silodosin with acetonitrile-water solution with a volume ratio of 70:30 to prepare a test solution containing about 10 mg of silodosin per 1 mL; accurately measure 1 mL of the test solution, place in In a 100mL volumetric flask, dilute to the mark with acetonitrile-water solution to obtain the test sample dilution, accurately weigh 3mL of the test sample dilution, place it in a 20mL volumetric flask, dilute to the mark with acetonitrile-water solution, and obtain the control solution.

[0052] Step S2, using acetonitrile-water solution with a volume ratio of 70:30 to dissolve silodosin and the reference substance of silodosin enantiomers to prepare silodosin and silodosin enantiomers per 1 mL Systemic suitability solution of 1 mg each.

[0053] In step S3, the test solution, control solution and system suitability solution are subjected to reverse-phase high-pe...

Embodiment 2

[0058] A method for detecting silodosin enantiomers, comprising:

[0059] Step S1, dissolve an appropriate amount of silodosin with acetonitrile-water solution with a volume ratio of 50:50 to prepare a test solution containing 10 mg of silodosin per 1 mL; accurately measure 1 mL of the test solution and place it in 100 mL In a volumetric flask, dilute to the mark with acetonitrile-water solution to obtain the dilution of the test sample, accurately weigh 3 mL of the dilution of the test sample, place it in a 20 mL volumetric flask, and dilute to the mark with acetonitrile-water solution to obtain the control solution.

[0060] Step S2, using the acetonitrile-water solution with a volume ratio of 50:50 to dissolve the reference substance of silodosin and silodosin enantiomers to prepare silodosin and silodosin enantiomers per 1 mL Systemic suitability solution of 1 mg each.

[0061] In step S3, the test solution, control solution and system suitability solution are subjected t...

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Abstract

The invention belongs to the field of medicines, and particularly relates to detection method and application of silodosin enantiomer. The method comprises the steps of preparing a silodosin test solution and a contrast solution; preparing a system adaptability solution of silodosin and the silodosin enantiomer; and performing reversed-phase high-performance liquid chromatography on the test solution, the contrast solution and the system adaptability solution, wherein the detection condition is as follows: a chromatographic column comprises a chiral chromatographic column taking silica gel surface covalently bonded with amylase-tri(3-chlorine-5-methyl phenyl carbamate) as a filling agent, a mobile phase comprises diammonium phosphate solution-acetonitrile, the flowing speed of the mobile phase is 0.7mL/min, the detection wavelength is 270 nanometers, and the column temperature of the chromatographic column is not larger than 30 DEG C. The detection method of the silodosin enantiomer, provided by the invention, is relatively good in sensitivity, relatively short in washing time, relatively small in balancing difficulty, favorable in reproducibility and favorable in durability, is convenient to operate and is of important significance to effective quality control of the silodosin.

Description

technical field [0001] The invention belongs to the field of medicines, and in particular relates to a detection method and application of silodosin enantiomers. Background technique [0002] The chemical name of silodosin is: 1-(3-hydroxypropyl)-5-[(2R)-2-({2-(2,2,2-trifluoroethoxy)phenoxy]ethyl base}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide, which contains a chiral carbon, so in silodosin there will inevitably be a pair of silodosin The enantiomer is: 1-(3-hydroxypropyl)-5-[(2S)-2-({2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino )propyl]-2,3-dihydro-1H-indole-7-carboxamide, and the existence of silodosin enantiomers will affect the purity of silodosin, while the existing The detection method of polysin enantiomer is mostly carried out by normal phase chromatography system, which has the disadvantages of long washing time, difficult equilibration, poor reproducibility and high requirements for high performance liquid chromatography. The detection method of silodosi...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/60
CPCG01N30/02G01N30/60
Inventor 李静程可建刘永强陈会武姜玉岗戴信敏
Owner 北京华氏康源医药科技有限公司
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