An Lc–esi-MS/MS Method Developmentand Its Validationfor the Quantification of Pralsetinib in K2edta Humanplasma

Objective: Aim of the work is to developa simple LC-ESI-MS/MS approach for a sensitive, specific, and quantitative determination of pralsetinib in human K2EDTA plasma. Methods: The samples were separated using an isocratic mobile phase made up of 0.1%HCOOH, methanol and acetonitrile in 10:70:20(% v/v) fractions. In multiple reaction monitoring mode, mass transitions for pralsetinib were m/z 534.27/302.19 and for asciminib internal standard, they were 450.1/257.10 in positive ionization mode. Results: Linearity and a high r2 value (>0.99) characterize the calibration curve, which spans 141.5–5660 ng/ml. Theintra-batchaccuracywaswithin-8.44 to 5.69% relative errorandtheprecisionwaswithin3.14 to 4.92%. Theinter-batchaccuracywaswithin-5.26 to 4.63% relative error and the precision was within 3.32 to 4.93%. The extraction recoveries executed at three quality control levels and their mean recovery was 97.45%. Conclusion: In conclusion, a new approach to evaluating pralsetinib in human K2EDTA plasma has been approved for use in clinical, bioavailability, and bioequivalence investigations, and it may be used to quantify pralsetinib.