Development and validation of a reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous determination of metronidazole, norfloxacin, and ciprofloxacin in bulk and pharmaceutical dosage forms

Background: A simple, accurate, and robust reversed phase high performance liquid chromatography (RP-HPLC) method was developed for the simultaneous determination of metronidazole, norfloxacin, and ciprofloxacin in bulk and pharmaceutical dosage forms. Objective: To develop and validate a RP-HPLC method for the simultaneous determinations of metronidazole, norfloxacin, and ciprofloxacin, Method: The separation was carried out on a C-18 column using a gradient mobile phase of potassium dihydrogen phosphate and acetonitrile at pH 3.3, with UV detection at 300 nm. The flow rate was 1 mL/min. The method was validated for specificity, linearity, precision, accuracy, and robustness, as per ICH guidelines. Results: The method showed linearity, accuracy, precision, and robustness. A multivariate analysis was used for the robustness study, and the method was successfully applied to assay commercial products containing the three drugs. Conclusions: The developed RP-HPLC method is reliable for routine quality control analysis of metronidazole, norfloxacin, and ciprofloxacin in pharmaceutical products.