RP-HPLC METHOD FOR QUANTIFICATION OF CEFIXIME AND OFLOXACIN ANTI-BACTERIAL AGENT IN BULK MATERIAL AND PHARMACEUTICAL FORMULATION

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ABSTRACTA simple, rapid, accurate, and precise reverse-phase high-performance liquid chromatographic(RP-HPLC) method was developed and validated for the simultaneous determination ofCefixime and Ofloxacin in bulk drug substances and pharmaceutical dosage forms.Chromatographic separation was achieved using a Fortis C18 column (150 mm × 4.6 mm, 2.5μm particle size) with a mobile phase consisting of acetonitrile and 0.05% orthophosphoric acidbuffer (pH 6.5 adjusted with 0.1% triethylamine) in the ratio of 80:20 (v/v). The mobile phasewas delivered at a flow rate of 1.0 mL/min, and detection was carried out at 286 nm using a UVdetector.The retention times of Cefixime and Ofloxacin were found to be 5.70 min and 3.04 min,respectively, with a total run time of less than 6 min. The method exhibited excellent linearityover the concentration ranges of 5–25 μg/mL for Cefixime and 40–200 μg/mL for Ofloxacin,with correlation coefficients (R2) of 0.9999 and 0.9996, respectively. The developed method wasvalidated according to ICH guidelines for system suitability, linearity, accuracy, precision,robustness, and sensitivity. The percentage recovery ranged from 99.54% to 100.99% forCefixime and 99.52% to 99.70% for Ofloxacin, confirming the accuracy of the method.Precision studies showed %RSD values below 2%, indicating good repeatability andintermediate precision. The limits of detection (LOD) and quantification (LOQ) were found to be0.66 μg/mL and 1.84 μg/mL for Cefixime and 2.11 μg/mL and 6.40 μg/mL for Ofloxacin,respectively. Assay results of marketed tablet formulations demonstrated satisfactory drugcontent with recoveries close to 100%.The developed RP-HPLC method was found to be simple, sensitive, reliable, and suitable forroutine quality control analysis of Cefixime and Ofloxacin in bulk and pharmaceutical dosageforms.

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