Development of a sensitive LC-MS/MS method for determination of -nitrosopiperazine in levocetirizine.

Levocetirizine is one of the widely used antihistamines and has the potential to form -nitrosopiperazine (NPZ) during drug synthesis, manufacturing, or storage. NPZ classified as a nitrosamine is a genotoxic impurity with carcinogenic properties. Controlling the presence of NPZ in the active pharmaceutical ingredient (API) and drug products is crucial with levels ideally maintained below 80 ppm.