DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF DASATINIB IN TABLET DOSAGE FORM
Journal Title: International Journal of Pharmaceutical Sciences and Research (IJPSR) - Year 2019, Vol 10, Issue 10
Abstract
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.
Authors and Affiliations
P. R. Sankar et al.
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