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Determination of ketorolac enantiomers in plasma using enantioselective liquid chromatography. Application to pharmacokinetic studies
Authors:M A Campanero  A López-Ocáriz  E García-Quetglas  B Sádaba  J R Azanza
Institution:(1) Osaka Laboratory, Japan Analytical Industry Co., Ltd., Unilife 303, 13-8, Higashimikuni 5, Yodogawaku, 532 Osaka, Japan;(2) Laboratory, Japan Analytical Industry Co., Ltd., 208 Musashi, Mizuho, Nishitama, 190-12 Tokyo, Japan;(3) Department of Materials Science, Tottori University, Koyama-minami 4-101, 680 Tottori, Japan
Abstract:Summary Residual synthetic adsorbent, cross-linked polystyrene, used in drug purification has been analyzed quantitatively by Curie-point pyrolysis gas chromatography. The peaks of intact polystyrene adsorbent in the pyrogram were used as key peaks for quantitative measurement of residues of the adsorbent in vitamin B1 and streptomycin sulfate. It was shown that them-ethylstyrene orp-ethylstyrene peaks in the pyrolyzates were suitable for determination of polystyrene adsorbent content. The levels of residual adsorbent in the drugs were found to be <0.1 %, the value stipulated by the International Conference on Harmonization (ICH). In quantitative evaluation of an adsorbent content of 0.1 % the precision was 3.6 % and 2.7 % for vitamin B1 and streptomycin sulfate, respectively.
Keywords:Gas chromatography  Pyrolysis GC  Residual polystyrene  Streptomycin  Vitamin B1
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