An Efficient LC-MS/MS Method for Determining N-nitroso Tofacitinib Toxicity In the Tablet Form

Abstract

Background and Objective: Pharmaceutical companies must adhere to rules established by regulatory agencies in order to monitor pharmaceutical products for nitrosamine contamination. One type of nitrosamine that can arise during the manufacture of the drug’s formulation and substance is N-Nitroso Tofacitinib. One pollutant that causes cancer is nitrosamines. Controlling the amount of nitrosamines in pharmaceuticals and medical supplies is essential. In this study, we devised a straightforward, sophisticated LC-MS/MS approach to analyse N-Nitroso Tofacitinib present in Tofacitinib tablets. Materials and Methods: Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) experiments were optimised on Jade C18 (5μ, 150 x 4.6 mm), solvent mixture was operated in gradient program using 10mM ammonium acetate pH 3.2 and acetonitrile with 1.0 mL flow rate. Mass transition (m/z) 275.3/149.1, 275.3 /147.0, and 275.3/82.1 are used Results: The range of linearity is 0.7 - 20.0 ng/mL, with r2 of 0.9952. The Lowest Detection (LOD) and quantification (LOQ) were 0.7 ng/mL and 1.0 ng/mL respectively. The recovery repeatability was found to be within the specified range. Conclusion:: The new approach proved effective for quantifying N-Nitroso Tofacitinib impurity in Tofacitinib Tablet samples, indicating that it could be applied for regular analysis.