Implementation of Quality by Design Approach to the Analytical Method Development and Validation for the Estimation of Rosuvastatin Calcium

Quality by Design (QbD) refers to the achievement of certain predictable quality with a predetermined and desired specification. The current studies details QbD enable the development of a simple, rapid, sensitive, and cost-effective high-performance liquid chromatographic method for the estimation of rosuvastatin calcium. The factor screening studies were performed using a 3-factor 12-trials 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 quality attribute (CQA), viz., retention time, peak tailing, and theoretical plate as per the parameter of the method robustness. The optimal chromatographic separation was achieved using acetonitrile and water 75:25 v/v as the mobile phase with a flow rate of 1 mL/min by using a PDA detector at 24 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 minutes leads to a cost-effective and environment-friendly chromatographic procedure. Thus, the proposed method reviled that rapid and represented a good procedure for rosuvastatin calcium.