Advanced Eco-Friendly Novel RP-HPLC Method for Estimation of Dasatinib in Tablets by Qbd: Greenness Assessment through GAPI and AGREE

Abstract

 Introduction: An advanced Eco-friendly novel chromatographic method was developed and validated for the estimation of Dasatinib in tablet dosage form by Quality by design approach. Design of experiments was applied for the optimization for RP-HPLC method and greenness of the method was evaluated. Materials and Methods: Preliminary screening trials along with systemic risk analysis were performed, endeavouring to explicate the critical method attributes (CMAs), namely Amount of organic modier, Flow rate and pH of buffer that inuence critical quality attributes (CQAs). Boxbehnken design was employed to study the response surface methodology for analyzing the interaction of each three level on Retention time(R1) and Tailing factor(R2) were considered as response factors. The RP-HPLC method of Dasatinib was successfully developed and validated according to ICH Q2(R1) guidelines with respect to linearity, accuracy, precision, robustness, Limit of Detection and Limit of Quantitation. The greenness scale of developed method using the “analytical GREENness (AGREE)” and “Green Analytical Procedure Index (GAPI)” approach. Results and conclusion: The regression data for the calibration plots exhibits linear relationship over a concentration range 5-25 µg/ml. The % RSD for both inter- day and intra- day precision was less than 2%. Percent recovery of Dasatinib was found to be more than 99%. The assay was found to be 99.95 ± 0.23%. AGREE and GAPI was applied to proposed analytical method and showed an excellent greenness characteristic of the present approach. The developed eco-friendly method was accurate, precise, and cost effective. Developed greener chromatographic method can be used for routine analysis of Dasatinib