{"title":"稳定性指示反相高效液相色谱法测定片剂中氨硫pride的含量","authors":"S. S","doi":"10.21276/bpr.2019.9.9","DOIUrl":null,"url":null,"abstract":"A new stability indicating RP-HPLC method was development and validation done for Amisulpride in tablet dosage form. RP-HPLC method was performed for estimation of dosage form and degradants. The method utilizes a mobile phase Acetonitrile:water in the ratio of 60:40 v/v and a flow rate of 1 ml/min with the UV detection at 226 nm for Amisulpride (AMP). The retention time was found to be 4.635 min for Amisulpride. The linearity was found to be in the concentration range of 5-30 μg/ml (r2=0.999) for AMP. Forced degradations were carried out under acid, base, thermal, photolytic and oxidative stress conditions. The method was satisfactorily validated as per the ICH guideline.","PeriodicalId":9368,"journal":{"name":"Bulletin of Pharmaceutical Research Institute","volume":"72 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"4","resultStr":"{\"title\":\"STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF AMISULPRIDE IN TABLET DOSAGE FORM\",\"authors\":\"S. S\",\"doi\":\"10.21276/bpr.2019.9.9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"A new stability indicating RP-HPLC method was development and validation done for Amisulpride in tablet dosage form. RP-HPLC method was performed for estimation of dosage form and degradants. The method utilizes a mobile phase Acetonitrile:water in the ratio of 60:40 v/v and a flow rate of 1 ml/min with the UV detection at 226 nm for Amisulpride (AMP). The retention time was found to be 4.635 min for Amisulpride. The linearity was found to be in the concentration range of 5-30 μg/ml (r2=0.999) for AMP. Forced degradations were carried out under acid, base, thermal, photolytic and oxidative stress conditions. The method was satisfactorily validated as per the ICH guideline.\",\"PeriodicalId\":9368,\"journal\":{\"name\":\"Bulletin of Pharmaceutical Research Institute\",\"volume\":\"72 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2019-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"4\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Bulletin of Pharmaceutical Research Institute\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.21276/bpr.2019.9.9\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Bulletin of Pharmaceutical Research Institute","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.21276/bpr.2019.9.9","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF AMISULPRIDE IN TABLET DOSAGE FORM
A new stability indicating RP-HPLC method was development and validation done for Amisulpride in tablet dosage form. RP-HPLC method was performed for estimation of dosage form and degradants. The method utilizes a mobile phase Acetonitrile:water in the ratio of 60:40 v/v and a flow rate of 1 ml/min with the UV detection at 226 nm for Amisulpride (AMP). The retention time was found to be 4.635 min for Amisulpride. The linearity was found to be in the concentration range of 5-30 μg/ml (r2=0.999) for AMP. Forced degradations were carried out under acid, base, thermal, photolytic and oxidative stress conditions. The method was satisfactorily validated as per the ICH guideline.
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