Dionex has released an application note detailing an improved method for determining concentrations of cefepime and related substances in pharmaceutical formulas.
Application note 205, entitled '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, 3um column, and an optimised gradient to determine cefepime concentration and purity faster than described in the United States Pharmacopeia (USP) and European Pharmacopeia (EP) monographs.
The 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 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.
