A practical HPLC-MS method for the analysis of nitrosamine drug substance related impurities using an inexpensive single quadrupole mass spectrometer.

Nitrosamine drug substance related impurities (NDSRIs) are often analyzed using high performance liquid chromatography (HPLC) with mass spectrometry (MS) detection. Due to high sensitivity requirements, high resolution MS or MS/MS is commonly used. However, it is difficult to implement this type of method for routine analysis at a supply site.