Reverse-phase High-performance Liquid Chromatography: High-performance Liquid Chromatography Method Used for Estimating Cefuroxime Axetil in Tablet and Bulk Dosage Formulations

A BSTRACT Background: Cefuroxime axetil, an effective second-generation cephalosporin antibiotic, requires valid analytical technique for bulk medication and tablet quality control. Aim and Objective: The current study developed a speedy, efficient, accurate, and cost-effective RP-HPLC (Reverse Phase High Performance Liquid Chromatography) technology that has been developed and validated for the quantification of Cefuroxime axetil in bulk and pharmaceutical formulations using a C8 column. Materials and Methods: The chromatography method employed a Base Deactivated Silica(BDS)-Hyperil C8 column (250 × 4.6 mm, 5 microns) with a mobile phase of acetonitrile and water at a 55:45 v/v ratio, at a flow rate of 1.025 ml/min. The method supports green principles was analyzed using a Shimadzu-LC-20AT HPLC system at a wavelength of 277 nm. The approach was assessed in accordance with ICH(International Council for Harmonisation) criteria. Results and Discussion: The results indicated the trustworthiness of the marketed formulation (cefakind 500 mg), with a purity of 99.09%. The retention time of Cefuroxime Axetil was 4.349 ± 0.02 minutes, with a correlation value ( R ²) of 0.9998, demonstrating excellent linearity within the 30-70 µg/mL range. The limits of detection (LOD) and quantification (LOQ) were 0.0180 µg/ml and 0.0546 µg/ml, respectively. The average recovery was 99.09%, guaranteeing exceptional precision. The approach demonstrated accuracy (% RSD = 0.06) and robustness against minor fluctuations in analytical conditions. The suggested RP-HPLC method is straightforward, swift, precise, accurate, and cost-effective, rendering it appropriate for regular quality control, dissolution analysis, and bioequivalence assessment of Cefuroxime axetil in pharmaceutical formulations.