New Development Method for Determination of Cefuroxime Axetil (CUA) and Cefprozil (CZ) in Pharmaceutical Drugs by RP-HPLC

Abstract

High performance liquid chromatography was one of the most important technologies used in drug control and pharmaceutical quality control. In this study, an analytical method was developed using chromatography method for determination of two Cephalosporin as like: Cefuroxime Axetil (CUA), and Cefprozil (CZ) in pharmaceutical Drug Formulations. Isocratic separation was performed on an Enable C18 column (125mm × 4.6mm i.d, 5.0μm, 10A˚) Using Triethylamine: Methanol: Acetonitrile: Ultra-Pure Water (0.1: 5: 25: 69.9 v/v/v/v %) as a mobile phase at flow rate of 1.5 mL\min. The PDA detection wavelength was set at 262nm. The linearity was observed over a concentration range of (0.01–50μg\mL) for RP-HPLC method (correlation coefficient=0.999). The developed method was validated according to ICH guidelines. The relative standard deviation values for the method precision studies were < 1%, and an accuracy was > 98%. The results were within the limits allowed by the US Pharmacopoeia and successfully for determination of Cefuroxime Axetil (CUA) and Cefprozil (CZ) in Tablets and dry syrup of the local pharmaceutical formulations