Formulation of the racecadotril capsules (100mg), method validation and stability studies

Introduction: Product characterization is aimed at identifying attributes that are critical for the quality of a drug product. Such are design, analytical method validation, and stability studies strengthening the product development data. Undertaken, racecadotril 100 mg capsules for diarrhea treatment entails the entire development study.

Methodology: Six formulations of racecadotril 100 mg capsules were prepared with different excipients at varied concentrations. HPLC method was validated on analytical parameters recommended by ICH Q2R guidelines. Forced degradation studies were performed as per Stability Indicating Method (SIM) under various conditions. Accelerated stability studies were performed and kept for 6 months. The dissolution profile of the stable formulation was compared with the innovator brand.

Results: Amongst all formulations, F6 was the best fit having a comparatively good dissolution profile with 76.9 % release in 60 minutes. HPLC system was suitable as % RSD was 0.619147 % that is within the acceptance criteria. Other parameters like specificity, accuracy and recovery, precision, quantitation limit, detection limit, range, linearity, and robustness laid within the acceptance criteria. The percent degradation of racecadotril after photolytic (sunlight for 6 hr.), oxidative (3% H2O2), acidic and basic stress was found to be 6.5%, 5.8%, 11.4%, and 28.4%, respectively. The product remains unchanged after thermal stress.

Conclusions: F6 formulation of racecadotril 100 mg capsule was marked successful amongst all with HPLC method validation. Accelerated stability studies and forced degradation studies enforced that the F6 formulation is stable while the model-independent approach comprising of similarity and difference factors confirmed that the undertaken product is comparable with the marketed brand.