Response Surface Methodology for the Optimized and Validated Investigation of Ropivacaine in Bulk and Tablet Dosage form by RP – HPLC

Abstract

This study explains the response surface methodology-based novel RP-HPLC method for determining and validating ropivacaine in bulk and tablet dosage form. The effect of three critical, independent variables, the volume of ACN (acetonitrile) in the mobile phase, flow rate and wavelength on the responses Retention time, tailing factor, and Theoretical plates, were studied using Box- Behnken designs. The design was statistically analyzed using ANOVA, normal plot of residual, Box-Cox plot, perturbation, and 3D response surface plots. The quadratic model was used to predict response values. Chromatographic separation was obtained by ODS C18,5µm column with Isocratic elution. The mobile phase used is Acetonitrile (ACN): Methanol: Water (40:30:30) v/v, with 0.1% TEA. The flow rate was 1.5ml/min, and detection was carried out at 270nm. Retention time, R2, was 6.670mins and 0.9892, respectively. The %RSD was not more than 2.0% in accuracy. The validation of the optimized chromatographic method was carried out as per ICH guidelines. The DOE using Box- Behnken design explained a significant effect of the mobile phase on the responses. The results show that the method is accurate, simple, reproducible, economical, robust, and rapid for routine qualitative analysis.