Development of an LC-MS/MS technique and its validation for the determination of infigratinib in human K2EDTA plasma; Pharmacokinetics in healthy rabbits

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dc.contributor.authorAnusha, Ken_US
dc.contributor.authorSowjanya, Gen_US
dc.date.accessioned2024-11-30T11:21:19Z
dc.date.available2024-11-30T11:21:19Z
dc.date.issued2024-09
dc.description.abstractA 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.en_US
dc.identifier.affiliationsDepartment of Pharmacy, GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmacy, GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India.en_US
dc.identifier.citationAnusha 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. Journal of Applied Pharmaceutical Science. 2024 Sept; 14(9): 148-155en_US
dc.identifier.issn2231-3354
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/237693
dc.languageenen_US
dc.publisherOpen Science Publishers LLPen_US
dc.relation.issuenumber9en_US
dc.relation.volume14en_US
dc.source.urihttps://doi.org/10.7324/JAPS.2024.171011en_US
dc.subjectInfigratiniben_US
dc.subjectcanceren_US
dc.subjectLC-MS-MSen_US
dc.subjectvalidationen_US
dc.subjectaccuracyen_US
dc.subjectkinetics in rabbits.en_US
dc.titleDevelopment of an LC-MS/MS technique and its validation for the determination of infigratinib in human K2EDTA plasma; Pharmacokinetics in healthy rabbitsen_US
dc.typeJournal Articleen_US
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