Impurity Profiling of Antihyperglycemic Drug-Sitagliptin

Antihyperglycemic medication known as sitagliptin is frequently prescribed to treat diabetes mellitus. It is a DPP-4 inhibitor, which provides a fresh treatment strategy for lowering glucagon levels. By using easily accessible starting materials, we offer a straightforward, practical, and effective approach for the synthesis of six impurities found in sitagliptin, including phenyl ethyl amine, triazole, acid, alkene, cyclohexyl, and enantiomer impurities. Simple methods like GLC, GC-MS, and HPLC can be used to analyze these contaminants. It is feasible to confirm the presence of these synthetic impurities in the sitagliptin by co-injecting them and comparing the retention time with spiking impurities. Impurities are utilized in pure form to validate the relative response factor, robustness, LOD, and LOQ of the procedure.