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 Δ 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 Δ 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 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 Δ 3-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 Δ 3-cefuroxime axetil.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
