Development and Validation of New RP-HPLC Method for the Estimation of Dasatinib in Pharmaceutical Dosage Forms


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Volume :

5

Issue :

2

Abstract :

A simple, precise, accurate RP-HPLC method was developed and validated for the estimation of Dasatinib in pharmaceutical dosage forms. An Cosmicsil BDS C18 column (150 mm x 4.6 mm), 5 µ particle size was used as stationary phase with mobile phase consisting of Phosphate buffer: a mixture of acetonitrile and methanol in the ratio of 50:50, v/v. The flow rate was maintained at 1 mL/min and effluents were monitored at 315 nm. The retention time was 6.4675 min. The linearity of the method was observed in the concentration range of 20-60 µg/mL with correlation coefficient of 0.999. The percentage assay of Dasatinib was 100.10%. The method was validated for its accuracy, precision and system suitability. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the estimation of Dasatinib in pharmaceutical dosage forms.

Keyword :

Dasatinib, Cosmicsil BDS C18 column, RP-HPLC, Validation
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