Determination of Cefuroxime Axetil and Cefixime Trihydrate in Pharmaceutical Dosage Forms by RP-HPLC Method

Abstract

Determination of two generation Cephalosporins (Cefuroxime Axetil and Cefixime Trihydrate) in pharmaceutical dosage forms was carried out employing High Perfeormance Liquid Chromatographic using isocratic separation. Separation was performed on an Enable C18 column (250 mm × 4.6 mm, 5.0 μm) using Triethylamine: Methanol: Acetonitrile: Ultra-Pure Water (2:10:20:68 v/v%) as the mobile phase at a flow rate of 1.0 ml/min. The PDA detection wavelength was set at 265 nm. The linearity was observed over a concentration range of 0.1-80 μg/ml for HPLC method (correlation coefficient=0.999). The developed methods were validated according to ICH guidelines. The relative standard deviation values for the method precision studies were <2%, and the accuracy was >99%. The developed method was used successfully for the determination of Cefuroxime Axetil, Cefixime Trihydrate, in Capsule, Tablet and dry syrup formulations.