STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF RABEPRAZOLE SODIUM AND MOSAPRIDE CITRATE IN BULK AND FORMULATION

摘要

Objective: Development and validation of reversed phase liquid chromatographic method for the quantitative determination of Rabeprazole sodium and Mosapride citrate in bulk and combined dosage form. Methods: A thermo Inert sil, C 18 (250 x 4.6 mm i. d., 5 μ) column with mobile phase containing methanol: buffer (ammonium acetate pH 6.5): acetonitrile in the ratio of (50:20:30 %) was used. The flow rate was 1.0 ml/min, column temperature was 25 °C and effluents were monitored at 245 nm. Results: The retention times of Rabeprazole sodium and Mosapride citrate were 2.951 min and 4.195 min, respectively. Correlation co-efficient for Rabeprazole sodium and Mosapride citrate was found to be 0.9999 and 0.9999, respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity, and robustness. Recovery of Rabeprazole sodium and Mosapride citrate in formulations was found to be in the range of 97-103 % and 98-102 %, respectively confirms the non-interferences of the excipients in the formulation. Conclusion: The proposed HPLC method was found to be simple, precise, accurate and sensitive for the simultaneous estimation of Rabeprazole sodium and Mosapride citrate in pharmaceutical dosage forms. Due to its simplicity, rapidness and high precision, the method was successfully applied to the estimation of Rabeprazole sodium and Mosapride citrate in combined dosage form. Keywords: RP-HPLC, Rabeprazole sodium, Mosapride citrate, Methanol, Acetonitrile, Validation.