A stability indicating assay method for cefuroxime axetil and its application to analysis of tablets exposed to accelerated stability test conditions

Cefuroxime axetil is the esterified form of cefuroxime, injectable second generation cephalosporine antibiotic that can be given orally. Stereo and structural isomers of cefuroxime axetil (CA), anti-cefuroxime axetil (ACA) and Δ3-cefuroxime axetil (DCA), can be present in cefuroxime dosage forms as the process related impurities as well as possible degradation product. Sensitive and precise reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of cefuroxime axetil in the presence of its degradation products in solid dosage forms. The RSD values for cefuroxime axetil, anti-cefuroxime axetil and Δ3-cefuroxime axetil of 1.80, 1.99 and 2.48%, respectively, indicated a good precision of the RP-HPLC method. Developed RP-HPLC method was sensitive with LOD = 0.08 μg mL−1 and LOQ = 0.60 μg mL−1 for anti-cefuroxime axetil and LOD = 0.06 μg mL−1 and LOQ = 0.45 μg mL−1 for Δ3-cefuroxime axetil. Holding studies were carried out on Ceroxim® tablets, according to ICH regulation at 30 °C/60% relative humidity (RH) and 40 °C/75% RH for 1, 2, 3 and 6 months. The review data from the stability studies conducted, show the significant content change of Δ3-cefuroxime axetil.