Development and Optimization of Stability-Indicating Method of Solifenacin Succinate and Its Main Product of Degradation in Tablet Dosage Form Using the Quality by Design Approach

This work presents the development and optimization of the stability-indicating method for solifenacin succinate and its main degradation product, formed through oxidation, using the high-performance liquid chromatography technique with diode array detection using the quality by design approach. In this work, a forced degradation study was performed to evaluate the potential degradation profile of the active ingredient, solifenacin succinate. Here, multiple optimizations of the extraction procedure are proposed. Often, the prescribed procedure focuses on recovering the active pharmacological ingredient while neglecting the recovery of impurities, a critical step in the development of stability-indicating methods. In this step, an experimental design of mixtures using the simplex model was used in order to optimize the recovery of the active ingredient and its main degradation product. Mixture solvents were evaluated by combining water (0–40