A precise and linear liquid chromatography tandem mass spectrometry technique was developed for the estimation of infigratinib in human K2EDTA plasma. Chromatographic isolation of infigratinib and dasatinib was attained on orosil, 3 μm, C18, 150 × 4.6 mm stationary phase with a 0.8 ml/minute movable phase flow rate. The method was rectilinear in a concentration range of 1–1,640 ng/ml. Validation showed an r2 = 0.9997 and an equation of y = 0.0015x − 0.0063. The average accuracies of back-assessed concentrations for all quality controls (QCs) were between 96.34 and 100.76. At medium QC, high-QC, and low-QC concentrations, infigratinib had 98.14%, 96.36%, and 97.21% mean recoveries, respectively. Retention time %CV findings were ≤0.62 for the analyte and dasatinib, respectively. The developed method was successfully applied to the pharmacokinetic studies of infigratinib in healthy rabbits. The Cmax, Tmax, and T1/2, of the infigratinib tablets were 87.25 } 1.43 ng/ml, 6.0 } 0.03 hours, and 15.24 } 0.53 hours, respectively. AUC 0–∞ infinity for infigratinib tablets was 291.74 } 3.67 ng h/ml. The developed method was successfully validated and can be utilized for the assessment of infigratinib in biological matrices at industries, forensic laboratories, QC laboratories, and bioavailability studies.
Anusha K, Sowjanya G. Development of an LC-MS/ MS technique and its validation for the determination of infigratinib in human K2EDTA plasma; Pharmacokinetics in healthy rabbits. J Appl Pharm Sci. 2024. Online First. http://doi.org/10.7324/JAPS.2024.171011
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