Study of nonvolatile degradation compounds produced by radiosterilization of cefotaxime

N. Barbarin and B. Tilquin

Université catholique de Louvain, Unité d’Analyse Chimique et Physico-chimique des Médicaments, UCL 72.30. Av. E. Mounier, 72, B-1200 Bruxelles, Belgium


The effects of radiosterilization on the purity profile of cefotaxime were evaluated by a liquid chromatography-diode array method. Numerous new radiolytic compounds were detected in very small amount. They were quantified and it appeared that none was present above the level of 0.1% of the main compound and the total amount was only of 0.72%. Despite the low quantities present, some radiolytic compounds had UV spectra which could justify the apparition of a yellow coloration detected after irradiation. Others had UV spectra similar to that of cefotaxime, suggesting similarity in the molecular structures. Finally, some mechanisms of formation were proposed for four radiolytic compounds which were identified by mass spectrometry in a former study.

Author Keywords: Radiosterilization; Cefotaxime; Color modification; HPLC; Lactam; Radiolytic compounds