Stability study of cefepime in different infusion solutions

The stability of cefepime in the formulation Axepim(R) diluted with 0.9% sodium chloride or with 5% glucose in a three layer laminate bag Clear-Flex(R) (polyethylene container) was investigated at 24 +/- 2 degrees C in daylight and at 4 +/- 2 degrees C in the dark (initial concentration was 8 mg ml(-1)). Stability was defined as at least 90% of the initial concentration. Analyses were performed by reversed phase high performance liquid chromatography, with a method previously validated. This was specific, linear (r greater than or equal to 0.9995), sensitive (CV < 0.44%) and reproducible (CV < 1.26%). The limit of detection was 0.1 mu g ml(-1) and limit of quantification was 1 mu g ml(-1). This study showed the changes in the stability of cefepime over 48 h at 24 +/- 2 degrees C in daylight, or 15 days at 4 +/- 2 degrees C in the dark. The yellowish coloration which appeared in some solutions, indicated visually a degradation of cefepime. IR and NMR spectra showed that this coloration was linked to the destruction of the Delta-cephem ring of the molecule. (C) 1997 Elsevier Science B.V.