A Novel Validated GC–MS/MS Method for the Estimation of N-Nitroso Dimethyl Amine and N-Nitroso Diethyl Amine in Zidovudine.

This article focuses on the development and validation of a novel gas chromatography–tandem mass spectrometry (GC–MS/MS) method for detecting and quantifying N-Nitroso dimethyl amine (NDMA) and N-Nitroso diethyl amine (NDEA) impurities in Zidovudine, an antiretroviral drug used to treat HIV/AIDS. The method, validated according to International Conference on Harmonization (ICH) guidelines, achieves sensitive detection limits (0.006 ppm) and quantitation limits (0.018 ppm) without interference from Zidovudine itself, using a DB-WAX column and a straightforward sample preparation. Batch analyses of Zidovudine samples showed NDMA and NDEA levels below detection limits, indicating effective removal of these potentially carcinogenic impurities during manufacturing. This approach offers a rapid, precise, and robust alternative to existing methods, facilitating quality control of Zidovudine with respect to nitrosamine contamination.