Development and Validation of Analytical Method for Simultaneous Estimation of Ranitidine and Bismuth Subsalicylate by RP-HPLC

A simple, precise, and accurate Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Ranitidine and Bismuth Subsalicylate in bulk drug substances and pharmaceutical formulations. Chromatographic separation was achieved using a Phenomenex Luna C18 column (4.6 × 150 mm, 5 mm) maintained at a column temperature of 45°C. The mobile phase consisted of Methanol and Water in a ratio of 80:20 v/v, delivered at a flow rate of 1.0 mL/min. Detection was performed at a wavelength of 230 nm, with an injection volume of 10 µL and a total run time of 10 minutes. Both analytes were well resolved with sharp and symmetrical peaks and showed satisfactory retention times. The method was validated according to ICH guidelines, and the results confirmed the method's linearity, precision, accuracy, specificity, and robustness.