{"title":"RP-HPLC法测定多卢替拉韦和利匹韦林的含量及片剂剂型的建立与验证","authors":"P. Pravalika, G. T. Rani, P. T. Sree, Y. Saritha","doi":"10.18579/jopcr/v20i3.ms21040c","DOIUrl":null,"url":null,"abstract":"S T A C T An accurate and precise method was developed and validated for the simultaneous estimation of the Dolutegravir and Rilpivirine in Tablet dosage form. Chromatogram was run using Agilent C 18 column (4.6x150mm, 5 m m) with mobile phase containing KH 2 PO 4 buffer of pH 3.5 and Acetonitrile in the ratio of 45:55 v/v was pumped through column at a flow rate of 1mL/min. Temperature was maintained at 30 ◦ C. Selected wavelength was 240.0 nm. Retention time of Dolutegravir and Rilpivirine was found to be 2.239 min and 2.899 min respectively. %RSD of the Dolutegravir and Rilpivirine for system precision was found to be 0.9 and 0.6 respectively. Accuracy was performed in triplicate and the % Recovery was obtained as 99.33% and 100.5% for Dolutegravir and Rilpivirine respectively. LOD, LOQ values for Dolutegravir was 0.2 m g/mL, 0.6 m g/mL and for Rilpivirine was 0.02, 0.06 m g/mL respectively. So, the method developed was simple,accurateandreproduciblecanbeadoptedinregularQualitycontroltestinpharmaceuticalIndustry.","PeriodicalId":16706,"journal":{"name":"Journal of Pharmaceutical Research","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2021-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Development and Validation of RP-HPLC Method for the Estimation of Dolutegravir and Rilpivirine in Bulk and its Tablet Dosage form\",\"authors\":\"P. Pravalika, G. T. Rani, P. T. Sree, Y. Saritha\",\"doi\":\"10.18579/jopcr/v20i3.ms21040c\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"S T A C T An accurate and precise method was developed and validated for the simultaneous estimation of the Dolutegravir and Rilpivirine in Tablet dosage form. Chromatogram was run using Agilent C 18 column (4.6x150mm, 5 m m) with mobile phase containing KH 2 PO 4 buffer of pH 3.5 and Acetonitrile in the ratio of 45:55 v/v was pumped through column at a flow rate of 1mL/min. Temperature was maintained at 30 ◦ C. Selected wavelength was 240.0 nm. Retention time of Dolutegravir and Rilpivirine was found to be 2.239 min and 2.899 min respectively. %RSD of the Dolutegravir and Rilpivirine for system precision was found to be 0.9 and 0.6 respectively. Accuracy was performed in triplicate and the % Recovery was obtained as 99.33% and 100.5% for Dolutegravir and Rilpivirine respectively. LOD, LOQ values for Dolutegravir was 0.2 m g/mL, 0.6 m g/mL and for Rilpivirine was 0.02, 0.06 m g/mL respectively. So, the method developed was simple,accurateandreproduciblecanbeadoptedinregularQualitycontroltestinpharmaceuticalIndustry.\",\"PeriodicalId\":16706,\"journal\":{\"name\":\"Journal of Pharmaceutical Research\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-09-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Pharmaceutical Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.18579/jopcr/v20i3.ms21040c\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Pharmaceutical Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.18579/jopcr/v20i3.ms21040c","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
S T A C T开发并验证了一种准确、精确的方法,用于同时测定片剂剂型中的多卢替格拉韦和利匹韦林。色谱图使用安捷伦C18柱(4.6x150mm,5 m m),流动相含有pH3.5的KH2 PO4缓冲液,乙腈以45:55 v/v的比例以1mL/min的流速泵送通过柱。温度保持在30◦ C.选择波长为240.0nm。多卢替格拉韦和利匹韦林的保留时间分别为2.239分钟和2.899分钟多洛替格拉韦和利匹韦林的系统精密度RSD分别为0.9和0.6。准确度一式三份,多卢替格拉韦和利匹韦林的回收率分别为99.33%和100.5%。多洛替格拉韦的LOD和LOQ值分别为0.2 m g/mL、0.6 m g/mL和利匹韦林的为0.02、0.06 m g/mL。因此,所开发的方法简单、准确,可在制药工业质量控制中重复使用。
Development and Validation of RP-HPLC Method for the Estimation of Dolutegravir and Rilpivirine in Bulk and its Tablet Dosage form
S T A C T An accurate and precise method was developed and validated for the simultaneous estimation of the Dolutegravir and Rilpivirine in Tablet dosage form. Chromatogram was run using Agilent C 18 column (4.6x150mm, 5 m m) with mobile phase containing KH 2 PO 4 buffer of pH 3.5 and Acetonitrile in the ratio of 45:55 v/v was pumped through column at a flow rate of 1mL/min. Temperature was maintained at 30 ◦ C. Selected wavelength was 240.0 nm. Retention time of Dolutegravir and Rilpivirine was found to be 2.239 min and 2.899 min respectively. %RSD of the Dolutegravir and Rilpivirine for system precision was found to be 0.9 and 0.6 respectively. Accuracy was performed in triplicate and the % Recovery was obtained as 99.33% and 100.5% for Dolutegravir and Rilpivirine respectively. LOD, LOQ values for Dolutegravir was 0.2 m g/mL, 0.6 m g/mL and for Rilpivirine was 0.02, 0.06 m g/mL respectively. So, the method developed was simple,accurateandreproduciblecanbeadoptedinregularQualitycontroltestinpharmaceuticalIndustry.