Lalit Dutta, Syed Imran Ahmad, Sanjeev Mishra, A. Khuroo, T. Monif
{"title":"选择性、灵敏、快速液相色谱-串联质谱法测定人血浆中格列美脲","authors":"Lalit Dutta, Syed Imran Ahmad, Sanjeev Mishra, A. Khuroo, T. Monif","doi":"10.3109/10601333.2011.647033","DOIUrl":null,"url":null,"abstract":"An analytical method based on liquid chromatography–tandem mass spectrometry (LC-MS-MS) was developed and validated for the determination of glimepiride in human plasma. Glimepiride and glimepiride-d4 (internal standard) were extracted from the plasma by solid phase extraction and chromatographed on a C18 analytical column using an isocratic mobile phase. Detection was carried out by positive electrospray ionization (ESI+) in multiple reaction monitoring (MRM) mode. The chromatographic separation was obtained within 2 min. Linearity was established from 1.00–500.00 ng/mL with a coefficient of determination (r2) of 0.9981 or greater. The lower limit of quantitation (LOQ) was identifiable and reproducible at 1.00 ng/mL with a precision of 3.8%. The method has shown remarkable reproducibility, with intra- and inter-day precision and accuracy <11.3% and <11.0%, respectively. The method was successfully applied for the quantitation of glimepiride in human plasma to support clinical and pharmacokinetic studies.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"51 1","pages":"15 - 22"},"PeriodicalIF":0.0000,"publicationDate":"2010-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"2","resultStr":"{\"title\":\"Selective, sensitive, and rapid liquid chromatography – tandem mass spectrometry method for determination of Glimepiride in human plasma\",\"authors\":\"Lalit Dutta, Syed Imran Ahmad, Sanjeev Mishra, A. Khuroo, T. Monif\",\"doi\":\"10.3109/10601333.2011.647033\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"An analytical method based on liquid chromatography–tandem mass spectrometry (LC-MS-MS) was developed and validated for the determination of glimepiride in human plasma. Glimepiride and glimepiride-d4 (internal standard) were extracted from the plasma by solid phase extraction and chromatographed on a C18 analytical column using an isocratic mobile phase. Detection was carried out by positive electrospray ionization (ESI+) in multiple reaction monitoring (MRM) mode. The chromatographic separation was obtained within 2 min. Linearity was established from 1.00–500.00 ng/mL with a coefficient of determination (r2) of 0.9981 or greater. The lower limit of quantitation (LOQ) was identifiable and reproducible at 1.00 ng/mL with a precision of 3.8%. The method has shown remarkable reproducibility, with intra- and inter-day precision and accuracy <11.3% and <11.0%, respectively. The method was successfully applied for the quantitation of glimepiride in human plasma to support clinical and pharmacokinetic studies.\",\"PeriodicalId\":10446,\"journal\":{\"name\":\"Clinical Research and Regulatory Affairs\",\"volume\":\"51 1\",\"pages\":\"15 - 22\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2010-10-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Research and Regulatory Affairs\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3109/10601333.2011.647033\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Research and Regulatory Affairs","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3109/10601333.2011.647033","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Selective, sensitive, and rapid liquid chromatography – tandem mass spectrometry method for determination of Glimepiride in human plasma
An analytical method based on liquid chromatography–tandem mass spectrometry (LC-MS-MS) was developed and validated for the determination of glimepiride in human plasma. Glimepiride and glimepiride-d4 (internal standard) were extracted from the plasma by solid phase extraction and chromatographed on a C18 analytical column using an isocratic mobile phase. Detection was carried out by positive electrospray ionization (ESI+) in multiple reaction monitoring (MRM) mode. The chromatographic separation was obtained within 2 min. Linearity was established from 1.00–500.00 ng/mL with a coefficient of determination (r2) of 0.9981 or greater. The lower limit of quantitation (LOQ) was identifiable and reproducible at 1.00 ng/mL with a precision of 3.8%. The method has shown remarkable reproducibility, with intra- and inter-day precision and accuracy <11.3% and <11.0%, respectively. The method was successfully applied for the quantitation of glimepiride in human plasma to support clinical and pharmacokinetic studies.