Analytical method development and validation of Dasatinib in Bulk and pharmaceutical formulation using quality by design

The accurate, fast, cost effective and robust RP- HPLC chromatographic method was developed and validated by using Quality by Design approach as per the ICH guidelines, for Linearity, Accuracy, Interday-Intraday Precision, Specificity and Selectivity, Robustness, Solution stability. The Design of Experiment was carried out by using 3 level factorial designs using design expert software. Change in pH and Mobile Phase concentration is considered for design of experiment. Based on the results obtained from screening of various mobile phase Acetonitrile as to Water having proportion 50:50 at 4 pH and Maximum Wavelength 315nm were selected for the analysis of Dasatinib by employing QbD methodology. The 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, molar extinction coefficient (L mol-1 cm-1) suggested that the developed method is sensitive. The proposed high-performance liquid chromatographic method proved to be convenient simple, cost effective and effective for the quality control of Dasatinib.