LC-MS/MS Investigation of Nitrosamine Impurities in Certain Sartan Group Medicinal Products Available in Istanbul, T ürkiye

Ann Pharm Fr. 2023 Aug 9:S0003-4509(23)00079-2. doi: 10.1016/j.pharma.2023.08.002. Online ahead of print.ABSTRACTNitrosamines (NAs) are molecules that include the nitroso functional group. In 2018, the US Food and Drug Administration (FDA) received its first report of NAs in pharmaceuticals. The fact that NA impurities are likely human carcinogens is relevant to these compounds. Furthermore, prolonged exposure to NA contaminants above safe limits may raise the risk of cancer. The goal of this article was to assess the amounts of six different NAs in sartan group medicines purchased from formal pharmacies in Istanbul, Türkiye, using a validated LC-MS/MS assay. An LC-MS/MS-based analytical assay was undertaken. The separation was performed with a HR ODS 150 mm x 3.0 mm and 5 analytical columns, providing effective separation of major peaks from NA impurities. In mobile phase A, formic acid was 0.10% in water, while in mobile phase B, formic acid was 0.10% in methanol. The flow rate was 0.4 mL/minute, and the total runtime was 18 minutes with the gradient elution mode. The validation was conducted in line with ISO/IEC 17025 requirements. Up to 100 µg/L, linearity was determined using correlation coefficients (r2 > 0.995) for all NAs. The limit of quantification values for all NAs analyses were below 1.0 µg/L. The mean recovery value obtained during the spike experiment was 95.18%, demonstrating the accuracy of the procedure. In addition, the accuracy was shown by a certifi...
Source: Annales Pharmaceutiques Francaises - Category: Drugs & Pharmacology Authors: Source Type: research