Comprehensive UHPLC–MS screening methods for the analysis of triazolopyrazine precursor and its genotoxic nitroso-derivative in sitagliptin pharmaceutical formulation

Exploration and detection of nitrosamine impurity nitroso-STG-19 in sitagliptin tablets and API as well as nitrites in excipients by LC-MS/MS methods

“…There have been several reports on an analytical method for an NTTP test in a single API or drug product, but none of them explored the formation of NTTP, detected nitrites or provided an appropriate control strategy. 10,11 Ion chromatography (IC) is the most common technology for the analysis of nitrites. 12 Nevertheless, IC was insufficient to detect trace nitrites because of the greater sensitivity required.…”