DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF DASATINIB IN TABLET DOSAGE FORM

The objective of the present study was to develop and validate a novel RP-HPLC method for the determination of Dasatinib in the pharmaceutical dosage form. Chromatographic separation was conducted on agilent technologies-1260 series with the G1311C quaternary pump, Thermo Scientific C18 column (4.6 mm i.d. x 250 mm, 5 mu m particle size) and equipped with photodiode array detector G1315D. The mobile phase consisted of methanol and acetonitrile mixed in the ratio of 50: 50 v/v, was used at a flow rate of 1 ml/min, and the detection wavelength was set at 323 nm. The retention time for Dasatinib was found to be 4.073 min. The calibration was linear (r(2) = 0.999) in the concentration range of 2-10 mu g/ml. The limit of detection and the limit of quantitation were found to be 0.5263 mu g/ml and 1.5948 mu g/ml, respectively. Recovery of Dasatinib in tablet formulation was observed in the range of 98.09-99.57%. Percentage assay of Dasatinib (Dasanat) was found to be 99.45% w/w. Thus the novel proposed method for Dasatinib was found to be feasible for the estimation of Dasatinib in bulk as well as the pharmaceutical dosage form.