Multi-criteria decision making approach and experimental design as chemometric tools to optimize HPLC separation of domperidone and pantoprazole.

This paper deals with multiple response simultaneous optimization using the Derringer's desirability function for the development of a reversed-phase HPLC method for the simultaneous determination of domperidone and pantoprazole in commercial pharmaceutical preparations. Twenty experiments, taking the retention factor of the first peak, the two resolutions, and three retention times as the responses with three important factors, mobile phase composition, buffer molarity and flow rate, were used to design mathematical models. The experimental responses were fitted into a second order polynomial and the six responses simultaneously optimized to predict the optimum conditions for the effective separation of the studied compounds. The optimum assay conditions were: methanol-acetonitrile-dipotassium hydrogen phosphate (pH 7.0; 15.3 mM) (20:33:47, v/v/v) as the mobile phase and at a flow rate of 1.19 ml/min. While using this optimum condition, baseline separation with a minimum resolution of 2.0 and a run time of less than 6 min were achieved. The method showed good agreement between the experimental data and predictive value throughout the studied parameter space. The optimized assay condition was validated according to ICH guidelines to confirm specificity, linearity, accuracy and precision.