Browsing by Author "Sowjanya, G"

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    Development of an LC-MS/MS technique and its validation for the determination of infigratinib in human K2EDTA plasma; Pharmacokinetics in healthy rabbits
    (Open Science Publishers LLP, 2024-09) Anusha, K; Sowjanya, G
    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, andT1/2, of the infigratinib tablets were 87.25 ± 1.43 ng/ml, 6.0 ± 0.03 hours, and 15.24 ± 0.53 hours, respectively. AUC0–? 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.