ANALYTICAL METHOD DEVELOPMENT AND OPTIMIZATION OF SOFOSBUVIR DRUG – A QbD APPROACH

Quality by Design (QbD) refers to the achievement of certain predictable quality with a predetermined and desired specification. The current studies details QbD enable development of a simple, rapid, sensitive and cost-effective High-Performance Liquid Chromatographic method for estimation of Sofosbuvir. The factor screening studies were performed using 5-factor 8-run 2-level factorial design. System thematic optimization was performed employing split-plot design by selecting the mobile phase ratio, buffer pH, and column type as the critical method parameter (CMPs) identified from screening studies, thus evaluating a critical analytical attributes (CAAs) namely, retention time, peak tailing, and theoretical plate as per the parameter of the method robustness. The optimal chromatographic separation was achieved using acetonitrile and ammonium acetate buffer (pH 4) 48:52 v/v as the mobile phase with a flow rate of 1.1 ml/min by using a PDA detector at 262 nm. The method was validated as per the ICH-recommended conditions, which ensure a high degree of linearity, accuracy, precision, sensitivity, and robustness over the exiting liquid chromatography methods of the drug. Moreover, the lower solvent consumption along with the short analytical run time of 10 min leads to a cost-effective and environment-friendly chromatographic procedure. Thus, the proposed method reviled that rapid and represented a good procedure for Sofosbuvir.