Validation of an HPLC Method for Determination of Cefepime (a Fourth-Generation Cephalosporin). Determination in Human Serum, Cerebrospinal Fluid, and Urine. Pharmacokinetic Profiles

A high-performance liquid-chromatographic method with detection at 256 nm has been developed and validated for analysis of cefepime in several biological matrices. Serum samples were deproteinized with acetonitrile and extracted once with dichloromethane. For urine and cerebrospinal fluid samples, only a microfiltration step was necessary. The method was validated in accordance with the recommendations of the International Conference on Harmonization (ICH), the Food and Drug Administration (FDA), and the Center for Drug Evaluation and Research (CDER). The method was used to determine levels of the drug in the serum, cerebrospinal fluid, and urine of twelve patients treated with Maxipime. The results obtained were compared with those from previously published HPLC methods.