DEVELOPMENT AND VALIDATION BY RP HPLC METHOD OF MOXIFLOXACIN AND LEVOFLOXACIN IN BULK AND PHARMACEUTICAL FORMULATION

A simple, precise, and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of moxifloxacin and levofloxacin in bulk drug substances and pharmaceutical formulations. Chromatographic separation was achieved using a Symmetry ODS C18 column (4.6 mm × 150 mm, 5 µm particle size) maintained at 38°C, with a mobile phase comprising methanol and water in the ratio of 64:36 v/v. The elution was performed at a flow rate of 1.0 ml/min, and detection was carried out at a wavelength of 220 nm using a Waters Alliance 2695 HPLC system coupled with a PDA Detector (996 model). The injection volume was 20 µl, and the total run time was 7.0 minutes. The method was validated according to ICH guidelines for parameters such as linearity, accuracy, precision, specificity, and robustness. The retention times of moxifloxacin and levofloxacin were well-resolved with no interference from formulation excipients, indicating the method’s suitability for routine quality control. The developed method offers a reliable, efficient, and cost-effective approach for the simultaneous quantification of these two fluoroquinolone antibiotics in various pharmaceutical dosage forms. Keywords: RP-HPLC, moxifloxacin, levofloxacin, Symmetry ODS C18 column, simultaneous estimation, validation, Waters Alliance 2695 HPLC.