Abstract:
In this study, we present a systematic approach to develop a robust LC-MS method for analyzing NDMA in metformin HCl products using an Evosphere AQUA column. This method effectively retains and separates NDMA from DMF and other sample matrices, offering superior sensitivity even with a simple single quadrupole mass spectrometer. The method has been successfully validated according to ICH Q2(R2) guidelines and applied to the analysis of NDMA in both instant release and extended release metformin HCl drug products.
Authors:
Mikhaila D. Ritz(a), Ana I. Martinez (a), Timothy Yaroshuk (b), Xihui Liang (a), Xiaoyi Gong (a), Mark D. Mowery (a), and Jinjian Zheng (a*)