A CAPILLARY GC-MS ANALYSIS OF RESIDUAL ETHANESULFONATES IN TENELIGLIPTIN

IF 0.5 Q4 EDUCATION & EDUCATIONAL RESEARCH

Rasayan Journal of Chemistry Pub Date : 2023-01-01 DOI:10.31788/rjc.2023.1628311

M. Manivannan, P. Parthiban, P. Ilayaraja

引用次数: 0

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.

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替尼格列汀中残留乙磺酸盐的毛细管气相色谱-质谱分析

药物中残留的磺酸酯是潜在的基因毒性杂质(pgi)，因此需要一种特定的方法来根据监管当局的指导方针对药物中的残留磺酸酯进行量化。在此基础上，优化并验证了采用气相色谱-质谱联用技术评价Teneligliptin药物中乙磺酸乙酯(EES)和乙磺酸异丙酯(IPES)的方法。EES和IPES的检测限(LOD)和定量限(LOQ)分别为3.75和11.25 ppm。在11.25和56 ppm之间观察到线性关系。EES和IPES的平均回收率分别为102.65%和102.21%。该方法精密度高，准确度高，专属性好，线性性好;因此，该方法可用于测定特尼格列汀和其他格列汀类药物的EES和IPES。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Rasayan Journal of Chemistry Energy-Energy (all)

CiteScore

1.90

自引率

0.00%

发文量

196

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.