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Method for determining silodosin impurities by virtue of HPLC process

A technology for silodosin impurities and silodosin, which is applied in the field of silodosin determination, can solve the problems of unstable nature, easy degradation, and unavailability of silodosin impurity detection, and achieves high sensitivity and exclusive use. The effect of good performance and short analysis time

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

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Problems solved by technology

[0004] Silodosin has a chiral center, is unstable in nature, and is prone to degradation, etc. Therefore, a determination method for its impurities must be established to ensure the quality control of the final product
In order to ensure the safety and effectiveness of the drug, it is necessary to study, detect and monitor the impurities in the raw materials of the drug. At present, most of the patents on silodosin are related to the synthesis and preparation methods, but there is no available analysis for the detection of silodosin impurities. method is reported

Method used

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  • Method for determining silodosin impurities by virtue of HPLC process
  • Method for determining silodosin impurities by virtue of HPLC process
  • Method for determining silodosin impurities by virtue of HPLC process

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Embodiment 1

[0038] A method for HPLC method to measure silodosin impurity, described method comprises the steps:

[0039] S1. Preparation of system suitability solution: take a silodosin sample, expose to light, add methanol to the irradiated silodosin sample, and shake well to obtain a system suitability solution;

[0040] S2, preparation of reference substance solution: add methanol to the silodosin reference substance, shake well to obtain the reference substance solution;

[0041] S3, preparing the test product solution: add methanol to the silodosin test product, shake up to obtain the test product solution;

[0042] 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 chromatograph respectively, record chromatogram Figu...

Embodiment 2

[0044] A method for HPLC method to measure silodosin impurity, described method comprises the steps:

[0045] S1. Preparation of system suitability solution: take a silodosin sample, expose to light, add methanol to the irradiated silodosin sample, and shake well to obtain a system suitability solution;

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

[0047] S3, preparing the test product solution: add methanol to the silodosin test product, shake up to obtain the test product 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 chromatograph respectively, record chromatogram Figu...

Embodiment 3

[0053] A method for HPLC method to measure silodosin impurity, described method comprises the steps:

[0054] S1. Preparation of system suitability solution: take a silodosin sample, expose to light, add methanol to the irradiated silodosin sample, and shake well to obtain a system suitability solution;

[0055] S2, preparation of reference substance solution: add methanol to the silodosin reference substance, shake well to obtain the reference substance solution;

[0056] S3, preparing the test product solution: add methanol to the silodosin test product, shake up to obtain the test product solution;

[0057] 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 chromatograph respectively, record chromatogram Figu...

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Abstract

The invention discloses a method for determining silodosin impurities by virtue of an HPLC process. The method comprises the following steps: preparing system suitability solution; preparing referencesolution; preparing test solution; and performing chromatography, namely taking the system suitability solution, injecting into a liquid chromatograph, and recording a chromatogram map I; taking thereference 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 is relatively short in analysistime, good in specificity and high in sensitivity and can rapidly, effectively and accurately performs quantitative analysis on related substances in silodosin raw materials, thereby guaranteeing thata medicine is safe and effective.

Description

technical field [0001] The invention relates to the technical field of silodosin determination, in particular to a method for determining silodosin impurities by HPLC. 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, that is, silodosin is a medicinal ingredient, and its structural formula is as follows: [0003] [0004] Silodosin has a chiral center, is unstable and prone to degradation, etc. Therefore, it is necessary to establish a determination method for its impurities to ensure the quality control of the final product. In order to ensure the safety and effectiveness of the drug, it is necessary to study, detect and monit...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74G01N30/86
CPCG01N30/06G01N30/74G01N30/8634
Inventor 黄欢黄庆国赵东伟
Owner ANHUI QINGYUN PHARMA & CHEM
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