Detection method and application of silodosin enantiomer

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...

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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 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 silodosin enantiomer is of great significance to effectively control the quality of silodosin

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