Optimization of UPLC Method for Simultaneous Determination of Rosuvastatin and Rosuvastatin Degradation Products.

An ultra-performance liquid chromatographic method for simultaneous determination of rosuvastatin and rosuvastatin degradation products was developed and optimized by using fractional factorial experimental design. Optimized method is capable to accurately determine all potential degradation products of rosuvastatin. During the optimization the effect of four chosen chromatographic factors was evaluated. The analytical method operational design region was modeled using Umetrics MODDE software and optimal chromatographic conditions were predicted. The results of the model show that the most important factors to reach good separation between the peaks of rosuvastatin impurities are the pH of buffer solution and the amount of ACN and THF in the mobile phase. The final optimized method using QbD approach was validated for linearity, accuracy and precision for determination of rosuvastatin and rosuvastatin degradation products in rosuvastatin pharmaceutical dosage forms. Limit of detection and quantification were determined for two known specified impurities. The use of experimental designs enabled us to obtain the maximum amount of information about the analytical method design region. Optimization of the method was done without additional experiments, only weighing the responses and rebuilding the statistical model. This approach is very cost-effective when evaluating a variety of different factors and their interactions.