title: A stability indicating assay method for cefuroxime axetil and its application to analysis of tablets exposed to accelerated stability test conditions.
abstract: 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.
authors.affiliation: Department of Separation Technology, Mallinckrodt Baker BV, AA Deventer, The Netherlands. ivana.ivanovic@emea.tycohealthcare.com
authors.forename: Ivanovic
authors.initials: I
authors.lastname: Ivana
authors.forename: Zivanovic
authors.initials: Z
authors.lastname: Ljiljana
authors.forename: Zecevic
authors.initials: Z
authors.lastname: Mira
mesh_terms: D002444:Cefuroxime / Q000031:analogs & derivatives* / Q000032:analysis; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013607:Tablets / Q000737:chemistry
chemical_list: D013607:Tablets; D002444:Cefuroxime; C040738:cefuroxime axetil