Design, Characterization, Analytical HPLC Method Validation, and Stability Studies of Racecadotril Capsules

Abstract

This study aims to develop, characterize and validate analytical method and perform stability studies of Racecadotril capsules to treat acute diarrhea. Six formulations of Racecadotril 100mg Capsules were prepared with different excipients by varying their concentrations. The HPLC method was validated on analytical parameters recommended by ICH Q2R guidelines, including specificity, accuracy and recovery, precision, quantitation limit, detection limit, range, linearity, and robustness. Forced degradation studies were performed as per the Stability Indicating Method under various stress conditions. Accelerated stability studies were performed on three stability batches of best fit formulation of Racecadotril 100mg Capsules as per ICH guidelines. Among the six formulations of Racecadotril 100mg Capsule, F6 was the best fit with a comparatively good dissolution profile with 76.9% release in 60 minutes. The HPLC system was suitable as % R.S.D. was 0.619147%, within the acceptance criteria. Furthermore, parameters including specificity, accuracy and recovery, precision, quantitation limit, detection limit, range, linearity, and robustness lie within the acceptance criteria. The percent degradation of Racecadotril after photolytic (sunlight for 6 hr.), oxidative (3% H2O2), acidic (0.1N HCl) and necessary (0.1N NaOH) stress was found to be 6.5%, 5.8%, 11.4%, and 28.4%, respectively. The product remains unchanged after thermal stress. HPLC method was successfully validated for Racecadotril 100mg Capsule as per ICH Q2R guidelines.