| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 1210169 | Journal of Chromatography A | 2006 | 7 Pages |
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.
