Consistency Evaluation of Dissolution of Generic and Original Preparations of Sulindac Tablets

Introduction: Sulindac is a non-steroidal anti-inflammatory drug (NSAID) primarily used to alleviate pain and inflammation associated with various arthritides (e.g., rheumatoid arthritis, osteoarthritis) and soft tissue injuries.To ensure consistent drug release and therapeutic efficacy, a reliable dissolution method must be established for quality control.This research systematically investigates and validates the dissolution method for sulindac tablets.Methods: The 0.2-g strength was selected for dissolution method validation, including investigation of specificity, linear range, filter membrane adsorption, accuracy, precision, robustness, stability, and recovery rate.Dissolution profiles for self-made tablets (0.1 g and 0.2 g) and the reference listed drug (RLD) were evaluated in multiple dissolution media (0.1 mol/L hydrochloric acid, pH 4.5 acetate buffer, and pH 6.8/pH 7.2 phosphate buffer).Results: The dissolution method validation demonstrated that all indicators met the requirements, including no interference from blanks, a good linear relationship, negligible membrane adsorption, excellent precision and stability, a satisfactory recovery rate, and strong robustness.In phosphate buffer (pH 6.8 and 7.2), the dissolution profiles of the test products and RLDs were similar (f2 > 50). Conclusion:The validated dissolution method is accurate and reliable, effectively facilitating the dissolution testing and quality evaluation of sulindac tablets.