A highly selective, sensitive, and rapid high performance liquid chromatographic (HPLC) method has been developed and validated to quantify dasatinib, a tyrosine kinase inhibitor, in rabbit plasma. Montelukast was used as internal standard (IS). Dasatinib and IS were extracted by deproteinization technique, followed by injection of aliquot of supernatant into chromatographic system. Chromatographic separation was achieved on a reversed phase C18 column with a mobile phase of 0.02M potassium dihydrogen phosphate:methanol (10:90, v/v) pumped at flow rate of 2.0mL/min. The analytes were detected at 340 and 374nm for excitation and emission, respectively. The assay exhibited a linear range of 50.0-3000ng/mL, with a lower detection limit of 15.0ng/mL. The method was statistically validated for linearity, accuracy, precision, selectivity and stability following FDA guidelines. The intra- and inter-assay coefficients of variation did not exceed 13.5% from the nominal concentration. The accuracy of dasatinib was within ±15% of the theoretical value. The assay has been applied successfully in a pharmacokinetic study.
Keywords: Dasatinib; HPLC; Method of validation; Pharmacokinetic study; Rabbit plasma.
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