Cefepime, a fourth generation cephalosporin (Wikipedia link), is a broad spectrum antibiotic with improved activity against Gram-negative bacteria (Wikipedia link) over other commercially available cephalosporin drugs. The importance of cephalosporins lies in the fact that they have low toxicity and their broad range of antimicrobial activity against Gram-negative and Gram-positive bacteria have resulted in being the most prescribed antibiotics to treat bacterial infections.
However, the analysis of cefepime purity faces the following challenges:
- Cefepime has structural similarities to its impurities.
- Cefepime is unstable and will degrade slowly even during storage at 4 °C. Degradation of cefepime includes cleavage of the R2 side chain and opening of the β-lactam ring to yield 2-[[(2-amino-4-thiazolyl) ((Z)-methoxyimino) acetyl]amino]acetoaldehyde and N-methylpyrrolidine. The primary concern with degradation is loss
of potency and the potential toxicity of degradation products to patients.
Here, we discuss an improved analytical method using HPLC with UV detection that reduces the separation time by almost half analytical throughput can be increased while maintaining compliance with methods published in pharmacopeial monographs! The method reduces separation time from 30 min to
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You can access the method in two ways:
- If you are using the Thermo Scientific Dionex Chromeleon Chromatography Data System (CDS) software, you candownload the cefepime method for immediate use.
- Application 205, Determination of Cefepime and Cefepime- Related Substances Using HPLC with UV Detection, (downloadable PDF) provides a comprehensive overview of the challenges in the analysis of cefepime and describes modifications to the related substances method to maximize either the speed or the resolution. The method uses the Thermo Scientific Acclaim 120 C18 Reversed-Phase liquid chromatography column, as defined by the USP.
For an IC method, check out Application Note 199, Determination of N-Methylpyrrolidine in Cefepime Using a Reagent-Free Ion Chromatography System (downloadable PDF). This application describes an IC method for the determination of NMP in cefepime preparations.
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