Reverse Phase High Performance Liquid Chromatographic Method for Simultaneous Determination of Cefuroxime Axetil and Potassium Clavulanate in Tablet Dosage Form

A simple, specific, accurate, and precise reverse phase high-performance liquid chromatographic method for analysis of Cefuroxime axetil and Potassium clavulanate has been developed. Separation of drugs was carried out on Jasco HPLC system with Hypersil Gold C-18 column (250 mm × 4.6 mm i.d.), using 0.01M Potassium dihydrogen phosphate: methanol 60: 40 (v/v) as mobile phase. Quantitation of drugs was carried out at wavelength 225 nm. Results were found to be linear in the concentration range of 5-50 μg/ml for CA and 5-30 μg/ml for PC. Mean retention times for Potassium clavulanate (PC) and the two isomers of Cefuroxime axetil (CA1 and CA2) were found to be 2.573, 8.293 and 9.987 min, respectively. Intra-day variation, as RSD (%), was 0.328 for Cefuroxime axetil and 0.382 for Potassium clavulanate. Interday variation, as RSD (%) was 0.545 for Cefuroxime axetil and 0.552 for Potassium clavulanate. The % assay was found to be 100.976 ± 0.439 for Cefuroxime axetil and 101.053 ± 0.423 for Potassium clavulanate (Mean ± S.D., n = 6).