【摘 要】
：
It is necessary to determine the macromolecule impurities content in β-lactam antibiotics for quality control.In China, the quality control method is usually performed by low-pressure gel filtration c
【机 构】
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Tosoh Bioscience Shanghai Co., Ltd, Shanghai 200233, China
【出 处】
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第2届大连国际色谱学术报告会、第37届国际高效液相色谱及相关技术会议、第18届全国色谱学术报告会
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It is necessary to determine the macromolecule impurities content in β-lactam antibiotics for quality control.In China, the quality control method is usually performed by low-pressure gel filtration chromatography system with dextran base packings, ranging in size from 40μm to 120μm.However, there are some problems for the conventional method found in practice, such as low column efficiency, poor repeatability for different people packing, longer analysis time and difficult to determine non-water soluble samples (cefuroxime axetil, cefpodoxime proxetil, etc.) In our study, some kinds of high performance gel chromatography methods have been developed for the analysis of macromolecule impurities in β-lactam antibiotics by using TSK-GEL high performance gel chromatography system.The strategy adopted is using high performance gel filtration chromatography columns for water-soluble samples and high performance gel permeation chromatography columns for non-water soluble samples.These methods have also been used for the analysis of macromolecule impurities in 21 kinds of water-soluble β-lactam antibiotics and 8 kinds of non-water soluble β-lactam antibiotics.
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