Development of Stability Indicating Method for the Quantification of Futibatinib in K2EDTA Human Plasma by LC-MS/MS

Abstract

sensitive, accurate, and linear LC-MS/MS method for the quantification of futibatinib in human plasma K2 ethylene diamine tetraacetic acid (EDTA) was developed. A Phenomenex C18, 150×4.60 mm, 2.1 μ column, 0.1% HCCOH, ACN and methyl alcohol (13/67/20, v/v/v) mobile solvent system at 0.8 mL/min was employed for the isolation of components.10 μL. of volumes were employed to isolate the peak responsess within 2.0 minutes at 40 ± 5ºC of oven temperature. Analyte retention was 1.261 minutes and ISTD of 1.292 minutes. Throughout the process of validation, each of the four calibration curves exhibited linear behavior for standards with concentrations ranging from 0.16 to 3250 ng/mL. Validation showed an r2 = 0.9997. At MQC, HQC, and LQC concentrations, futibatinib had 98.49, 99.35, and 98.47% mean recovery. Every QC level had a mean recovery of 90.51% and a %CV of 3.06. All of the control solutions had back-calculated concentration values that were accurate between 94.61 and 98.86% of the time. The range of %CV of back-calculated values for all quality control samples were in the range of 0.6 and 4.63, which is within the acceptable range of 15%. The developed method can be applied successfully for the quantification of the Futibatinib in biological matrices.