Quality by Design approach for a planar chromatographic method for simultaneous estimation of Ivabradine Hydrochloride and Carvedilol in pharmaceutical formulation

Abstract

AbstractBox‐Behnken design was applied for the development of a novel, precise, simple, and accurate high‐performance thin‐layer chromatography method for simultaneous estimation of mentioned drugs in the formulation. Optimization was performed using Quality by Design. Principles of risk assessment followed by application of design for optimization of chromatographic conditions to determine critical parameters: volume of hexane, chamber saturation time, solvent front and their effects on critical method attributes: Rf values of both drugs. Optimized conditions were determined through Derringer's desirability approach of the multi‐criteria decision‐making technique. Good resolution using optimized mobile phase, hexane:ethyl acetate:ammonium acetate in methanol (5.1:3:2) with Rf values 0.34 and 0.67 for Ivabradine Hydrochloride and Carvedilol, respectively, was obtained. The method was validated as per International Council on Harmonization having a linear range of 1000–5000 ng/band of Ivabradine and 1250–6250 ng/band for Carvedilol, respectively. %Recovery was in range of 99.23–101.3 and 99.8–100.5, respectively. Precision and robustness were found to be in an acceptable range. Thus, Quality by Design based method development assisted in making design space with knowledge of all method performance characteristics with a better understanding of high‐performance thin‐layer chromatography. The Analytical GREEnness profile was assessed using AGREE tool with an overall reliable score of 0.68.