LC-MS/MS Analytical Method Development and Validation for Determining Vinamidinium HexafluoroPhosphate Impurity in Etoricoxib

Abstract: Background and Aim: Process impurities may adversely affect the efficacy, excellent quality, safety of pharmaceutical drugs. Ultimately, purpose this research work was to develop validate a LC-MS/MS-based method for determining Vinamidinium hexafluorophosphate impurity (VHP) in Etoricoxib simple, specific, accurate, precise manner. Materials Methods: To elute at flow rate 0.5mL/min within 20.0 min runtime, Symmetry Shield RP18, 5μm column with 150 x 3.9 mm internal diameter utilized binary gradient mode. The buffer solution, which contained formic acid (0.1%) acetonitrile (100%), as well diluent solution (50%) water (50%), used achieve chromatographic separation. A triple quadrupole mass spectrometer (Shimadzu LC/MS/MS 8040) Multiple Reaction Monitoring (MRM) mode needed monitor results. Results Discussion: method's linearity evaluated levels from 25% 150%, R2 value discovered be 0.99. Sensitivity values 0.04μg/g (LOD) 0.13μg/g (LOQ) were established. recovery ranges 70.0% 130%. Linearity, specificity, accuracy, LOD, LOQ, precision all validated. Within assay variability limitations, it found that intra- inter-day 0.67%, 0.58%, respectively. Conclusion: According ICH FDA specifications, optimized developed appropriate quantifying by employing LC-MS. Keywords: Hexafluorophosphate (VHP), (ETC), International Conference on Harmonization, LC-MS/MS.