Application of Response Surface Methodology for the Development of an Innovative Stability-Indicating UHPLC Method for the Simultaneous Determination of Embelin and Vilangin in Vidanga (Embelia ribes) Tablets

Abstract

The current study highlights the systematic quality by design-assisted creation of an efficient analytical technique for the estimation of embelin and vilangin in Vidanga (Embelia ribes) tablets. Response surface methodology in the design of experiments was used to identify key material attributes and critical process parameters that influence the designated critical analytical attributes. Separation was achieved on the X-Bridge (100 × 2.1 mm, 2 μm). The effects of acetonitrile content (v/v), flow rate, and column temperature on the retention times of the two drugs and their resolution, number of theoretical plates, and tailing factor were investigated and optimized. The optimal chromatographic conditions within the design space were found to be an isocratic mobile phase consisting of buffer and methanol (57.77:42.33, v/v) with a flow rate of 0.2 mL/min and a run time of 3 min. The retention times of embelin and vilangin were found to be 1.31- and 1.7-min. Different validation parameters were established, and the approach was validated in agreement with ICH and FDA requirements. Data analysis using statistical methods has revealed that the method is reliable, accurate, and robust.