Analytical Method Development and Validation of Dasatinib in its Pharmaceutical Dosage Form by UPLC with Forced Degradation Studies

Author(s)

Rao, K. N. V., Srivani, P., Raja, M. A., Banji, D., Kumar, D. S.

Author's Affiliation

Abstract

A simple, accurate, precise, sensitive, rapid Ultra Performance Liquid chromatography (UPLC) method has been developed and validated for determination of Dasatinib in its pharmaceutical dosage form. Chromatographic separation was achieved on a Waters Acquity BEH C18 column(100 ×2.1mm,1.7), by a mobile phase consisted of Tri Ethyl Amine buffer(pH 6±0.05,maintained with ortho phosphoric acid) and Acetonitrile in 30:70(V/V) ratio with a flow rate of 0.8 ml/min. The detection wavelength was set at 322 nm. Dasatinib was subjected to different stress conditions like acid, alkali, and peroxide, thermal and checked for its specificity, degradation & stability. The method was linear (r = 0.999) at a concentration range of 5-25 μg/ml. The intra and inter day precisions were satisfactory; the relative standard deviations did not exceed 2%. The accuracy of the method was proved; the mean recovery of Dasatinib was 99.04-101.58%. The proposed method has high throughput as the analysis involved short run-time (2.5 mins). The method met the ICH/FDA regulatory requirements. The results demonstrated that the method can be applied successfully for routine use in quality control industry laboratories.

Keywords

Dasatinib, UPLC, validation, forced degradation

Cite This Article

Rao, K. N. V., Srivani, P., Raja, M. A., Banji, D., & Kumar, D. S. (2013). Analytical Method Development and Validation of Dasatinib in its Pharmaceutical Dosage Form by UPLC with Forced Degradation Studies. International Journal for Pharmaceutical Research Scholars (IJPRS), 2(4), 221-227.