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Objective: A reversed phase stability-indicating Ultra-Performance Liquid Chromatographic (UPLC) assay method was developed and validated for quantitative determination of Rabeprazole Sodium & Lafutidine in bulk drug and marketed dosage form. Method: a Phenomanex, C18 column, 150 × 2.5 mm, in Isocratic mode with mobile phase containing Acetonitrile: buffer (0.01 M Potassium di-hydrogen orthophosphate) pH 6.8 (60:40% v/v) was used. The flow rate was 1.2ml/min and detection was made at 215 nm. The retention time of Rabeprazole Sodium and Lafutidine was found to be 3.1 min and 5.8 min respectively. The developed method was validated using various analytical parameters viz., accuracy, linearity, precision, specificity, system suitability, robustness according to International Conference on Harmonization (ICH) Q2R1 guidelines. Result: The detector response was linear in the range of 40-120 μg/ml, 80-240 μg/ml for Lafutidine and Rabeprazole Sodium respectively and the readings of all the validation parameters are within the acceptance criteria. Conclusion: The Proposed UPLC method is reliable for the simultaneous estimation of Rabeprazole Sodium & Lafutidine in bulk and other solid dosage forms.
Rabeprazole Sodium, Lafutidine, RP-UPLC, ICH guidelines