{"title":"稳定性指示高效液相色谱法测定兰索拉唑中间体中有关物质","authors":"Balaji Nagarajan, G. Manoharan","doi":"10.29121/ijoest.v6.i3.2022.329","DOIUrl":null,"url":null,"abstract":"A novel, reversed-phase liquid chromatographic method was developed and validated for the determination of related substances in lansoprazole intermediate. Symmetric peak shape was on a C18 stationary phase with the dimensions of 250 mm column length, 4.6 mm as internal diameter, 5 microns particles with an economical and straightforward mass-compatible mobile phase combination of formic acid/triethylamine and acetonitrile delivered in gradient mode at a flow rate of 1.0 mL/min at 260 nm. The resolution between lansoprazole intermediate (LAN20) and its impurities (LAN20-I & LAN20-II) in the developed method was more than 2.0, indicating a significant separation. Regression analysis shows a correlation coefficient greater than 0.999 for lansoprazole intermediate and its related substances. The detection and quantitation limits of lansoprazole intermediate and its impurities are 0.01% and 0.005%. This method indicates that the recovery at different levels is 90 to 110% accurate. The test solution was stable in the diluent for 48 h and subjected to stress conditions. The mass balance was close to 99.5%.","PeriodicalId":331301,"journal":{"name":"International Journal of Engineering Science Technologies","volume":"39 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2022-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"STABILITY-INDICATING HPLC METHOD FOR THE DETERMINATION OF RELATED SUBSTANCES IN LANSOPRAZOLE INTERMEDIATE\",\"authors\":\"Balaji Nagarajan, G. Manoharan\",\"doi\":\"10.29121/ijoest.v6.i3.2022.329\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"A novel, reversed-phase liquid chromatographic method was developed and validated for the determination of related substances in lansoprazole intermediate. Symmetric peak shape was on a C18 stationary phase with the dimensions of 250 mm column length, 4.6 mm as internal diameter, 5 microns particles with an economical and straightforward mass-compatible mobile phase combination of formic acid/triethylamine and acetonitrile delivered in gradient mode at a flow rate of 1.0 mL/min at 260 nm. The resolution between lansoprazole intermediate (LAN20) and its impurities (LAN20-I & LAN20-II) in the developed method was more than 2.0, indicating a significant separation. Regression analysis shows a correlation coefficient greater than 0.999 for lansoprazole intermediate and its related substances. The detection and quantitation limits of lansoprazole intermediate and its impurities are 0.01% and 0.005%. This method indicates that the recovery at different levels is 90 to 110% accurate. The test solution was stable in the diluent for 48 h and subjected to stress conditions. The mass balance was close to 99.5%.\",\"PeriodicalId\":331301,\"journal\":{\"name\":\"International Journal of Engineering Science Technologies\",\"volume\":\"39 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-05-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Engineering Science Technologies\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.29121/ijoest.v6.i3.2022.329\",\"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 Engineering Science Technologies","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.29121/ijoest.v6.i3.2022.329","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
STABILITY-INDICATING HPLC METHOD FOR THE DETERMINATION OF RELATED SUBSTANCES IN LANSOPRAZOLE INTERMEDIATE
A novel, reversed-phase liquid chromatographic method was developed and validated for the determination of related substances in lansoprazole intermediate. Symmetric peak shape was on a C18 stationary phase with the dimensions of 250 mm column length, 4.6 mm as internal diameter, 5 microns particles with an economical and straightforward mass-compatible mobile phase combination of formic acid/triethylamine and acetonitrile delivered in gradient mode at a flow rate of 1.0 mL/min at 260 nm. The resolution between lansoprazole intermediate (LAN20) and its impurities (LAN20-I & LAN20-II) in the developed method was more than 2.0, indicating a significant separation. Regression analysis shows a correlation coefficient greater than 0.999 for lansoprazole intermediate and its related substances. The detection and quantitation limits of lansoprazole intermediate and its impurities are 0.01% and 0.005%. This method indicates that the recovery at different levels is 90 to 110% accurate. The test solution was stable in the diluent for 48 h and subjected to stress conditions. The mass balance was close to 99.5%.
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