Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF RABEPRAZOLE SODIUM AND LAFUTIDINE IN COMBINED DOSAGE FORM

Sanjivani Gorakhnath Borkar*

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Abstract

A simple, rapid, specific, accurate and precise RP-HPLC method was developed for the simultaneous estimation of Lafutidine and Rabeprazole Sodium in combined dosage form. A Hi Q sil C-8 Column (250 mm × 4.6 mm, 5 μm) in Isocratic mode with mobile phase containing Acetonitrile: Phosphate Buffer (70:30 v/v) pH 7.3 was used. The flow rate was 1.0ml/min and effluents were monitored at 230 nm. The retention time of Rabeprazole Sodium and Lafutidine was found to be 3.658 min and 5.408 min respectively. Validation parameters such as linearity, precision, accuracy, limit of detection(LOD), limit of quantification (LOQ), robustness were determined according to the International Conference on Harmonization (ICH) Q2R1 guidelines. The detector response was linear in the range for Lafutidine 10-60 μg/ml and for Rabeprazole Sodium 20-120 μg/ml. The proposed method was successfully applied for the simultaneous estimation of LAF and RAB in pharmaceutical dosage form.

Keywords: Lafutidine (LAF), Rabeprazole Sodium (RAB), RP-HPLC method.