Development and Validation of RP-HPLC Method for the Quantitative Analysis of Bempedoic acid in Bulk and Pharmaceutical Dosage form Using Surface Response Methodology

Abstract

Objectives: A specific and novel RP-HPLC method has been optimized for the quantitative analysis of bempedoic acid using response surface methodology. Method: Response surface methodology (RSM) helps in studying the empirical relationship between one or more measured responses and many independent variables in the form of a polynomial equation. Mapping of those responses related to the experimental domain helps in generating an optimized method. In this present study, the empirical relationship between measured responses like % organic phase, column temperature, and flow rate and independent variables like retention time and theoretical plates are drawn in the form of a polynomial equation and an optimized method was developed from that using Box-Behnken Design (BBD). Results: The analytes chromatogram was run through SB C18 100x1.8mm, 2μm. The optimized data from Design Expert software consists of 0.01% OPA: Acetonitrile (56.05:43.95%, v/v) as mobile phase pumped through column with 1.02ml/min flow rate at 30.09°C gave highest desirable function of 1. The retention times of the drug were found to be 2.231 min. The optimized method was validated as per instructions given in ICH Q2 (R1) guidelines. Conclusion: Based on the results of the analysis of variance, the selected model for the responses like retention time and tailing factor were found to be significant with p=0.05. 2D contour plots were inured to visualize the effect of factors and their interactions on the response.