Validation and Development of a Robust RP-HPLC Method for Simultaneous Estimation of Ciprofloxacin and Ornidazole in Pharmaceutical Formulations

A rapid, precise, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Ciprofloxacin and Ornidazole in pharmaceutical dosage forms. The method was optimized using a C18 column (250mm × 4.6mm, 5µm), with a mobile phase consisting of methanol and phosphate buffer (pH 3.5) in a ratio of 60:40 v/v, at a flow rate of 1.0mL/min. Detection was performed at 294nm. The method was validated per ICH guidelines, assessing parameters including specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and robustness. The results demonstrated that the method is suitable for routine quality control of Ciprofloxacin and Ornidazole in pharmaceutical preparations.