Use Of Chemometrics For Development And Validation Of RP-HPLC Method For Simultaneous Determination Of Dimenhydrinate And Cinnarizine

Pharmaceutical Science-Pharmaceutical analysis for Novel drug formulation

Abstract

A novel simple, sensitive, rapid and accurate isocratic RP-HPLC method was developed and validated for simultaneous determination of Dimenhydrinate and Cinnarizine applying statistical experimental design. Design of experiments (DoE) was applied for multivariate optimization of the experimental conditions of the RP-HPLC method. Three independent factors like; mobile phase composition, phosphate buffer strength and flow rate were employed to design mathematical models. Central composite design (CCD) was applied to study the response surface methodology. This study was used to find the deepness effects of these independent factors. Desirability function was used to simultaneously optimize the retention time and resolution of the analytes. Hence, our present study was aimed in finding the optimized and predicted data from the contour diagram. Mobile phase consisted of acetonitrile and ammonium acetate buffer (pH 7.0, strength 0.3 mM) in the ratio of 55:45%v/v respectively, at a flow rate of 1.7 mL/min was used. The present study objectives were to apply these optimum conditions baseline partition of both drugs with good resolution. The run time of less than 12.0 min was accomplished. The optimized assay conditions were validated according to ICH guidelines. The correlation coefficient value was found to be r2 = 0.9990 and 0.9993 for Dimenhydrinate and Cinnarizine respectively. LOD and LOQ value was found to be least concentration for both drugs. It indicates the method was highly sensitive. The accuracy %RSD value was found to be less than 2%. Consequently the reports clearly showed that Quality by design approach could be triumphantly applied to optimize RP-HPLC method for simultaneous determination of Dimenhydrinate and Cinnarizine.