QBD base stability indicating method development and validation of rocecadotril and its formulation

The present study aims to develop and validate a QbD-based stability-indicating RP-HPLC method for the estimation of Racecadotril and its pharmaceutical formulation. Using a systematic QbD approach, critical method parameters such as mobile phase composition and flow rate were optimized through Design of Experiments. Chromatographic separation was achieved on a Waters Reliant C18 column (4.6 × 250 mm, 5 µm) using a mobile phase of phosphate buffer and acetonitrile (45:55 v/v), with a flow rate of 1.5 mL/min and detection at 210 nm. The method demonstrated a retention time of approximately 8.5 minutes for Racecadotril. Stress degradation studies under acidic, basic, oxidative, and thermal conditions confirmed the stability-indicating nature of the method. Validation performed in accordance with ICH guidelines established the method’s specificity, accuracy, precision, sensitivity, and robustness. The developed method is suitable for routine quality control analysis of Racecadotril in both bulk drug and finished dosage forms.