DETERMINATION OF N-NITROSODIMETHYL AMINE (NDMA) AND N-NITROSODIETHYL AMINE (NDEA) IN MEDICINES CONTAINING SARTAN AND ITS DERIVATIVES

Abstract

Objective: In this study, it was aimed to determine the amounts of N-nitrosodimethyl amine (NDMA) and N-nitrosodiethyl amine (NDEA) in drugs containing sartan and its derivatives. Material and Method: Medicines containing sartan and its derivatives as active ingredients such as valsartan, losartan, telmisartan, olmesartan, candesartan, irbesartan were purchased from pharmacies. NDMA and NDEA amounts of drugs were determined by headspace GC-MS. Result and Discussion: The highest NDMA concentrations were found in drugs with losartan active ingredient (67.05±0.15mg kg-1), and the highest NDEA concentrations were found in drugs with candesartan (22.48±0.06 mg kg-1) and olmesartan (20.13 ± 0.06 mg kg-1) active ingredient. The NDMA contents in each tablet were between 3.6x10-4- 1.7x10-2 mg and the NDEA contents were between 3.3x10-4 – 8.8x10-3 mg. The acceptable daily intake limits specified by the European Medicines Agency and the Food and Drug Administration are 96 ng/day for NDMA and 26.5 ng/day for NDEA. It was observed that the values obtained were above the acceptable intake limits even if one tablet was taken per day.