Development of GC-MS/MS Method for Simultaneous Estimation of Four Nitrosoamine Genotoxic Impurities in Valsartan.

Objectives: Recently, -nitrosamines were unexpectedly detected in valsartan and other generic sartan products. Taking into this account, we developed a sensitive and stable multiple reaction monitoring mode-based "gas chromatography-tandem mass spectrometry (GC-MS/MS)" approach for the quantification of "four -nitrosamines" in valsartan, especially, -nitrosodiisopropylamine, -nitroso ethyl isopropylamine, -nitrosodiethylamine, and -nitrosodimethylamine.

Materials And Methods: GC and MS conditions were optimized with specificity, sensitivity, linearity, precision, and accuracy of the parameters.