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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF DASATINIB IN DASATINIB TABLET DOSAGE FORM

. A.D. Sravanthi, Ponnuri Bharath, P.Kiranmayi and D.Ramachandran


Abstract

A new, simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid Chromatography assay method has been developed for estimation of Dasatinib in tablet formulations. The separation was achieved by using column Zorbax SB-C18 (150x4.6mm, 3.5µ). The mobile phase-A consisted of pH 5.8 phosphate buffer and Acetonitrile in the ratio of (90:10 v/v) and mobile phase-B consisted of Water and Acetonitrile in the ratio of (10:90 v/v). The flow rate was 1.2 mL/min, column oven temperature 45°C and sampler cooler was maintained 25°C respectively and the Dasatinib was detected using UV detector at the wavelength of 320 nm and injection volume was 10μL. The retention time of Dasatinib was noted to be 4.10 min respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent.

Keywords: Dasatinib, Liquid chromatography, Force Degradation and Validation.

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