RP-UPLC Analytical Method Development for Simultaneous Estimation Camylofin and Mefenamic acid by Analytical QbD (AQbD)) Approach

Abstract

A simple, sensitive and reproducible RP-UPLC method developed for Camylofin and Mefenamic acid by using Analytical QbD (AQbD)) Approach. Quality by design (QbD) refers to the achievement of certain predictable quality with desired and predetermined specifications. A very useful component of the QbD is the understanding of factors and their interaction effects by a desired set of experiments. The present study describes the development of a comprehensive science and risk-based RP-UPLC method and subsequent validation for the analysis of Camylofin and Mefenamic acid using a quality by design approach. An efficient experimental design based on systematic scouting of key components of the RP‐UPLC method (column temperature and mobile phase composition) is presented. The outcome of the AQbD method is get the specified goals and boundaries for the retention time, area, Asymmetry and a composite desirability (D) of 1 was obtained, which gave the optimal flow rate of 0.3 ml/min. To confirm these optimum set of conditions, three replicate injections of 30 µg/ml Camylofin and Mefenamic acid was analyzed to determine if their observed retention time, asymmetry and theoretical plates were within the predicted ranges.