ABSTRACT:
The proposed RP-HPLC method, developed using the Quality by Design (QbD) approach, offers a simple, accurate, and reproducible method for the quality analysis of Suzetrigine. A 3 by 2 factorial design was employed to study the interaction between two factors, which were selected as dependent variables: mobile phase composition and flow rate. Independent variables, such as retention time and tailing factor, were assessed through the experimental runs in the design. The chromatographic method utilized a C-18 column, a PDA detector, and a mobile phase consisting of Acetonitrile and Phosphate buffer in a 60:40 (v/v) ratio, with a flow rate of 1 ml/min and a detection wavelength of 269 nm. The method was validated in accordance with ICH guidelines, and all validation parameters were thoroughly studied and carried out. All the results were found to be within the specified limits. The Quality by Design approach was successfully applied to develop the RP-HPLC method for Suzetrigine, and all key aspects of QbD were incorporated into the study.