RP-HPLC Method and its Validation for Analysis of Ofloxacin and Satranidazole in Bulk and Pharmaceutical Dosage Form

Abstract

A simple, precise, and accurate Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Ofloxacin and Satranidazole in bulk and pharmaceutical dosage forms. Chromatographic separation was achieved using a Phenomenex Luna C18 column (4.6 × 150 mm, 5 µm) with a mobile phase comprising Acetonitrile and Water (55:45 %v/v). The method employed a flow rate of 1.0 mL/min, UV detection at 262 nm, an injection volume of 10 µL, and a run time of 7 minutes. The drugs showed well-resolved, symmetrical peaks with retention times of approximately 2.3 minutes for Ofloxacin and 4.5 minutes for Satranidazole, with no interference from excipients. The method was validated according to ICH Q2(R1) guidelines, demonstrating excellent linearity (R² > 0.999), accuracy (recovery between 98–102%), precision (RSD < 2%), and specificity. The method showed adequate sensitivity with low limits of detection and quantitation, and robustness was confirmed under slight variations in chromatographic conditions.