PubMed · 11131341
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R Berner. 2000. Back to the basics.. https://doi.org/10.1007/pl00008359
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The stability of the amorphous form of cefuroxime axetil was studied by means of the stress stability test. The degradation was evaluated using the HPLC method with UV detection (278 nm), as described in the monograph of Cefuroxime Axetil in European Pharmacopoeia. Liquid chromatography was performed with a H5 SAS Hypersil column (5 microm particle size, 250 mmx4 mm), the mobile phase consisted of a mixture of 38 volumes of methanol and 62 volumes of a 23 g l-1 solution of ammonium dihydrogen phosphate, a flow rate of 1.2 ml min-1, and the internal standard was a solution of acetanilide in a mixture (1:1) of acetonitrile and water at a concentration of 0.2 mg ml-1. At an increased temperature at RH=0%, the degradation of cefuroxime axetil (CFA) diastereoisomers is the reversible first-order reaction, while that occurring in humid air (RH>25%) is the reversible first-order autocatalytic reaction with Delta3-isomers and E-isomers of cefuroxime axetil and cefuroxime as the main products.
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 Delta(3)-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 Delta(3)-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 microg mL(-1) and LOQ = 0.60 microg mL(-1) for anti-cefuroxime axetil and LOD = 0.06 microg mL(-1) and LOQ = 0.45 microg mL(-1) for Delta(3)-cefuroxime axetil. Holding studies were carried out on Ceroxim tablets, according to ICH regulation at 30 degrees C/60% relative humidity (RH) and 40 degrees C/75% RH for 1, 2, 3 and 6 months. The review data from the stability studies conducted, show the significant content change of Delta(3)-cefuroxime axetil.
BACKGROUND: Intravenous cefuroxime sodium solution could be prepared in advance by a centralized hospital pharmacy service to improve safety and time management. OBJECTIVE: To investigate the effect of freezing and microwave thawing on the solution stability of cefuroxime. METHODS: Cefuroxime 1.5 g in 100 mL of dextrose 5% in polyolefin bags was frozen individually (group A) or in one package (group B) for 98 days at -20 degrees C. The solutions were then thawed using microwaves at 270 (light cycle) or 800 watts (hard cycle) and stored at 4 degrees C. The cefuroxime concentration was measured by HPLC. Visual inspection was performed and pH was measured at that time. Stability of the solution was defined as a concentration remaining superior to 90% of the initial concentration by regression analysis. RESULTS: No color change or precipitation in the solutions was observed. In group A, stability was at least 23 and 21 days after light and hard cycle thawing, respectively. In group B, stability was at least 21 and 18 days, respectively, with the pH increasing without affecting chromatographic parameters. CONCLUSIONS: The optimal conditions for advance preparation of a solution containing cefuroxime 1.5% in dextrose 5% may be freezing of individual containers followed by a light cycle of microwave thawing.