Stability-Indicating LC Method for Simultaneous Estimation of Rabeprazole Sodium Hydrochloride and Itopride Hydrochloride in Combined Dosage Form

A simple, sensitive and precise stability indicating HPLC method has been developed for the estimation of rabeprazole and itopride in combined dosage form. A Phenomenex Gemini C-18, 5 μm column with a mobile phase containing 0.02 M ammonium acetate (pH 6): acetonitrile: methanol (45: 20: 35, v/v/v) was used. The flow rate was 1.0 mL min and effluents were monitored at 284 nm. Rabeprazole and itopride stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation and dry heat degradation. The proposed method was validated with respect to linearity, accuracy, precision and robustness. The retention times of rabeprazole and itopride were 8.8 and 3.8 min, respectively. The method was linear in the range of 0.4–20 μg mL for rabeprazole and 0.8–150 μg mL for itopride. The degraded product peaks were well resolved from the pure drug peak with significant differences in their retention time values. Stressed samples were assayed using the developed HPLC method. The method was successfully applied to the estimation of rabeprazole and itopride in combined capsule dosage forms. _____________________________________________________________________________________________________________