September 2008, Sunnyvale, CA—Dionex announces an improved method for determining concentrations of cefepime and cefepime-related substances in pharmaceutical formulations. Application Note 205: Determination of Cefepime and Cefepime-Related Substances Using HPLC with UV Detection describes the use of an UltiMate® 3000 HPLC system, an Acclaim® 120 C18, 3 µm column and an optimized gradient to determine cefepime concentration and purity faster than the methods described in the United States Pharmacopeia (USP) and European Pharmacopeia (EP) monographs. The application note also describes methods for improving resolution between cefepime-related substances.
Cefepime, a fourth generation cephalosporin, is a broad spectrum antibiotic with improved activity against Gram-negative bacteria over other commercially available cephalosporin drugs. Analysis of cefepime purity is particularly challenging due to isomeric and other impurities with similar structures. Additionally, cefepime is particularly labile and its stability is highly pH dependent, in part due to rapid N-methylpyrrolidine (NMP) cleavage at room temperature. This new method can be used to assure drug purity and potency, and compliance with USP and EP methods. A different Application Note, AN 199, describes an ion chromatography procedure for determining amounts of NMP in cefepime and cefepime for injection.
Dionex (NASDAQ:DNEX) is a global leader in the manufacturing and marketing of liquid chromatography and extraction systems, consumables, and software for chemical analysis. The Company's systems are used worldwide in environmental analysis and by the life sciences, chemical, petrochemical, food and beverage, power generation, and electronics industries. Our expertise in applications and instrumentation helps analytical scientists to evaluate and develop pharmaceuticals, establish environmental regulations, and produce better industrial products.
Acclaim and UlitMate are registered trademarks of Dionex Corporation.
