DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF DASATINIB IN TABLET DOSAGE FORMAbstract
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. × 250 mm, 5 µm 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 (r2 = 0.999) in the concentration range of 2-10 µg/ml. The limit of detection and the limit of quantitation were found to be 0.5263 μg/ml and 1.5948 µg/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.
P. R. Sankar * and S. Anusha
Department of Pharmaceutical Analysis, Vignan Pharmacy College, Vadlamudi, Andhra Pradesh, India.
23 January 2019
18 April 2019
13 June 2019
01 October 2019