Development and method validation on stress degradation studies ofcefpodoxime proxetil and clavulanic acid in dosage form by hplc method

摘要

A simple, precise, accurate and reproducible HPLC method developed and validated on stress degradation studies of Cefpodoxime proxetil and Clavulanic acid in dosage form (tablet). Cefpodoxime proxetil is a prodrug of cefpodoxime acid and supplied as racemic mixture of R- and S- enanatiomers. Clavulanic acid is used as b lactamase inhibitor. Cefpodoxime proxetil and Clavulanic acid were degraded together under different stress conditions by International Conference on Harmonization. The samples so generated were used to develop stability indicating HPLC method for two drugs. The drugs were well separated from degradation products using a reversed phase (C-18) column with a mobile phase composed of 20 mM ammonium acetate-acetonitrile-methanol (70:29:1) pumped at a flow rate of 1.5ml/min. the detection was carried out at 230nm. and the column temperature maintained at 300C. In this method the S isomer of Cefpodoxime proxetil was not degraded except in thermal condition where as R form of Cefpodoxime proxetil and Clavulanic acid sufficiently degraded in all the conditions. The method was validated for linearity, precision, accuracy, specificity, LOD and LOQ etc. the linearity range of Cefpodoxime proxetil and Clavulanic acid were found to be 150- 750 μg/ml and 200-1000 μg/ml respectively.