{"title":"波生坦片剂稳定性指示反相高效液相色谱法","authors":"R. Gaurkhede, A. Chandewar","doi":"10.7439/ijbar.v8i10.4456","DOIUrl":null,"url":null,"abstract":"A simple, precise and reproducible stability indicating HPLC method has been developed and validated for determination Bosentan on an Intersil ODS column (250*4.6*5um) using a mobile phase consisting of Disodium phosphate Buffer and acetonitrile (30:70) at flow 1.0 ml/min. Detection was carried out at 273nm . The method was validated with respect to specificity, accuracy linearity, precession, ruggedness and robustness parameters as per ICH guidelines. Linearity of the method was found to be 0.999; %RSD of precession was below 2.0%, recovery of added drug within 98-102 %, System suitability parameters were within limit for Bosentan. The Degradation study was performed during different stress conditions in stability studies. The results obtained in this research work are indicated that the developed method is simple, accurate and precise, sensitive and applicable for analysis in commercially available formulation sample.","PeriodicalId":13848,"journal":{"name":"International Journal of Biomedical and Advance Research","volume":"4 1","pages":"388-392"},"PeriodicalIF":0.0000,"publicationDate":"2017-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Stability Indicating RP-HPLC Method for Bosentan in Tablet Dosage form\",\"authors\":\"R. Gaurkhede, A. Chandewar\",\"doi\":\"10.7439/ijbar.v8i10.4456\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"A simple, precise and reproducible stability indicating HPLC method has been developed and validated for determination Bosentan on an Intersil ODS column (250*4.6*5um) using a mobile phase consisting of Disodium phosphate Buffer and acetonitrile (30:70) at flow 1.0 ml/min. Detection was carried out at 273nm . The method was validated with respect to specificity, accuracy linearity, precession, ruggedness and robustness parameters as per ICH guidelines. Linearity of the method was found to be 0.999; %RSD of precession was below 2.0%, recovery of added drug within 98-102 %, System suitability parameters were within limit for Bosentan. The Degradation study was performed during different stress conditions in stability studies. The results obtained in this research work are indicated that the developed method is simple, accurate and precise, sensitive and applicable for analysis in commercially available formulation sample.\",\"PeriodicalId\":13848,\"journal\":{\"name\":\"International Journal of Biomedical and Advance Research\",\"volume\":\"4 1\",\"pages\":\"388-392\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2017-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Biomedical and Advance Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.7439/ijbar.v8i10.4456\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Biomedical and Advance Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.7439/ijbar.v8i10.4456","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 Bosentan in Tablet Dosage form
A simple, precise and reproducible stability indicating HPLC method has been developed and validated for determination Bosentan on an Intersil ODS column (250*4.6*5um) using a mobile phase consisting of Disodium phosphate Buffer and acetonitrile (30:70) at flow 1.0 ml/min. Detection was carried out at 273nm . The method was validated with respect to specificity, accuracy linearity, precession, ruggedness and robustness parameters as per ICH guidelines. Linearity of the method was found to be 0.999; %RSD of precession was below 2.0%, recovery of added drug within 98-102 %, System suitability parameters were within limit for Bosentan. The Degradation study was performed during different stress conditions in stability studies. The results obtained in this research work are indicated that the developed method is simple, accurate and precise, sensitive and applicable for analysis in commercially available formulation sample.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
