Identification and evaluation of radiolysis products of irradiated chloramphenicol by HPLC-MS and HPLC-DAD |
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| Authors: | L Hong A Horni M Hesse H Altorfer |
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| Institution: | (1) Institute of Pharmaceutical Science, Swiss Federal Institute of Technology (ETH), 8057 Zurich, Switzerland;(2) Institute of Organic Chemistry, University of Zurich, 8057 Zurich, Switzerland |
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| Abstract: | Summary The radiolysis products of chloramphenicol under γ-radiation sterilization were investigated systematically. Eight main radiolysis
products were identified and quantified by HPLC-MS and HPLC-DAD, including two compounds never before reported. The minor
radiolysis products were quantified, which shows that they are at concentration levels<threshold for identification. Carbon-carbon
rupture reaction and oxidation reaction are proposed as the main radiolysis reactions of chloramphenicol powder. The applicability
of γ-sterilization for chloramphenicol products was evaluated quantitatively with qualitative and quantitative data that were
compared to the threshold requirements of international regulations for identification. It was concluded that toxicities of
the radiolysis products of chloramphenicol produced by γ-radiation sterilization can be neglected, the radiolysis products
are safe for human health from the chemical view. |
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| Keywords: | Column liquid chromatography Mass spectrometric detection Chloramphenicol Radiolytic products Gamma sterilization |
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