Determination of Nitrosamine Impurities in Sartan Drug Products by GC-MS/MS Method

Introduction

Drugs containing sartan APIs (active pharmaceutical ingredients), such as valsartan, candesartan, irbesartan, losartan and olmesartan, are used for treatment of hypertension and heart failure. Recently, US FDA has released findings of probable human carcinogens, N-nitrosodimethylamine (NDMA), Nnitrosodiethylamine (NDEA) and N-Nitroso-N-methyl-4- aminobutyric acid (NMBA) in sartan drug products and the affected medicines have been recalled. These nitrosamine impurities can form during the production of sartans that contain a functional group known as a tetrazole ring (Figure 1) under certain conditions. Additionally, the presence of the impurities in some sartans is possibly due to uses of contaminated equipment or reagents in the manufacturing process.

June 19, 2020 GMT