Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Dasatinib in Bulk and Niosomal Formulation

Abstract

The accurate, fast, cost effective RP- HPLC chromatographic method was developed and validated as per the ICH guidelines, for linearity, accuracy, interday-intraday precision, specificity and selectivity, robustness, solution stability. Current study is focused on the method development of dasatinib (DS) which is having anticancer activity by inhibiting tyrosine kinase enzyme. Standard curve of DS was constructed in methanol at λmax 325 nm using UV spectroscope. For RP-HPLC method development mobile phase used was acetonitrile: Potassium dihydrogen phosphate buffer in the ratio 60:40 %v/v, with flow rate of 1 mL/min at a temperature of 30 ℃. Maximum wavelength 325 nm were selected for the analysis of DS. The linearity of the solution was detected at 325 nm within the concentration range from 20 -120 µg/mL with a correlation value (R2) of 0.999975 indicating a very strong relationship between dependent and independent variables suggesting the accuracy of the method selected. The concentration of DS in niosomes was determined by the currently developed method. Validation parameters were used to evaluate, specificity, linearity, sensitivity, accuracy, precision, and ruggedness. About 98-102 (%v/v) of DS was found to be within standard limits and compliant with the standards set by the International Council of Harmonization (ICH) demonstrating the accuracy of the method used. The RP-HPLC method is more sensitive, accurate and precise compared to the previously reported method. There was no interference of excipients in the recovery study. The low value of %RSD was suggested that the developed method is sensitive. The proposed reverse phase high performance liquid chromatographic method proved to be convenient, simple and effective for the quality control of DS.