{"title":"A CAPILLARY GC-MS ANALYSIS OF RESIDUAL ETHANESULFONATES IN TENELIGLIPTIN","authors":"M. Manivannan, P. Parthiban, P. Ilayaraja","doi":"10.31788/rjc.2023.1628311","DOIUrl":null,"url":null,"abstract":"The presence of residual sulfonate esters in drugs is potentially genotoxic impurities (PGIs), thus demanding a need for a specific method to quantify them in the drug as per regulatory authorities’ guidelines. Accordingly, a GC-MS procedure was optimized and proved for the assessment of ethyl ethanesulfonate (EES) and isopropyl ethanesulfonate (IPES) in the Teneligliptin drug. The detection (LOD) and quantification (LOQ) limit values of EES and IPES were 3.75 and 11.25 ppm, respectively. A linear relationship was observed between 11.25 and 56 ppm. The mean recoveries of EES and IPES were 102.65 and 102.21%. The method is precise, accurate, specific, and linear; thus it can be employed to measure the EES and IPES in Teneligliptin and other gliptins.","PeriodicalId":21063,"journal":{"name":"Rasayan Journal of Chemistry","volume":"1 1","pages":""},"PeriodicalIF":0.5000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Rasayan Journal of Chemistry","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.31788/rjc.2023.1628311","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"EDUCATION & EDUCATIONAL RESEARCH","Score":null,"Total":0}
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Abstract
The presence of residual sulfonate esters in drugs is potentially genotoxic impurities (PGIs), thus demanding a need for a specific method to quantify them in the drug as per regulatory authorities’ guidelines. Accordingly, a GC-MS procedure was optimized and proved for the assessment of ethyl ethanesulfonate (EES) and isopropyl ethanesulfonate (IPES) in the Teneligliptin drug. The detection (LOD) and quantification (LOQ) limit values of EES and IPES were 3.75 and 11.25 ppm, respectively. A linear relationship was observed between 11.25 and 56 ppm. The mean recoveries of EES and IPES were 102.65 and 102.21%. The method is precise, accurate, specific, and linear; thus it can be employed to measure the EES and IPES in Teneligliptin and other gliptins.
期刊介绍：
RASĀYAN Journal of Chemistry [RJC] signifies a confluence of diverse streams of chemistry to stir up the cerebral powers of its contributors and readers. By introducing the journal by this name, we humbly intent to provide an open platform to all researchers, academicians and readers to showcase their ideas and research findings among the people of their own fraternity and to share their vast repository of knowledge and information. The journal seeks to embody the spirit of enquiry and innovation to augment the richness of existing chemistry literature and theories. We also aim towards making this journal an unparalleled reservoir of information and in process aspire to inculcate and expand the research aptitude.
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