Author: M. Manivannan , P. Parthiban and P. Ilayaraja

DOI: http://doi.org/10.31788/RJC.2023.1628311

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.

Keywords: Ethyl Ethanesulfonate, Isopropyl Ethanesulfonate, Sulfonate Ester, Teneligliptin, GC-MS.