GC-MS/MS: A TARGETED QUANTIFICATION OF POTENTIAL NITROSAMINE IMPURITIES IN APIXABAN

The detection and quantification of nitrosamine impurities in pharmaceutical products are critical due to their potential carcinogenicity. This study presents the development of a sensitive Gas Chromatography-Mass Spectrometry (GC-MS) method for the analysis of nitrosamine impurities in Apixaban drug substance. The method demonstrates high specificity, sensitivity, and compliance with regulatory guidelines, ensuring the safety and quality of Apixaban for therapeutic use. The method, designed to detect harmful contaminants in apixaban, performs effectively and meets all essential standards. The Mass spectrometry technique accurately confirmed the presence of NDMA, NDEA, and NEIPA at specified retention times. In accordance with established guidelines, the method underwent multiple parameters during development & validation ensuring its accuracy, sensitivity, and reliability, confirming the ability to detect these pollutants even at trace levels. The system operates continuously without interference from other pharmaceuticals, making it particularly suited for targeting these specific impurities. The method demonstrates the ability to detect minute quantities of nitroso-contaminants, utilizing well-established limits of detection and quantification. Recovery rates ranged from 96% to 103%, indicating high accuracy, precision, and minimal variability in results. Overall, this method is sensitive, precise, and consistent, thereby ensuring the safety and quality of apixaban in pharmaceutical products.