目的 对《中国药典》2010年版和《美国药典》36版中残留溶剂检测方法的异同进行了归纳与总结,以提高完善《中国药典》2015年版残留溶剂检测方法。 方法 分别在两国药典色谱条件下对适合顶空分析的52种残留溶剂进行分析,比较两国药典色谱条件的分离性能和互补性。 结果 《中国药典》条件下52种残留溶剂仅2种无法实现互补分离,而美国药典36版仅注重对第一、二类残留溶剂的分析,对其他类残留溶剂的互补分离效果明显较差。 结论 《中国药典》2010年版色谱条件较美国药典36版更适合残留溶剂分析,《中国药典》2015年版引入中等极性色谱系统,对残留溶剂的控制将更加完善。
Abstract
OBJECTIVE To summarize the differences and similarities of the detection METHODS of residual solvents between US Pharmacopoeia 36 edition and Chinese Pharmacopoeia 2010 edition, so as to improve the detection METHODS of residual solvents in Chinese Pharmacopoeia. METHODS Nonpolar and polar systems were used in Chinese Pharmacopoeia 2010, and medium polar and polar systems were used in US Pharmacopoeia 36. Fifty-two kinds of residual solvents were analyzed by the gas chromatography systems used in US and Chinese Pharmacopoeias respectively. And the resolution and complement of the two systems were compared. RESULTS Only 2 of 52 kinds of solvents which were suitable for headspace analysis in Chinese Pharmacopoeia could not be seperated. The US Pharmacopoeia focused on the first and second classes of residual solvents, and the identification of other classes of residual solvents were not perfect enough. CONCLUSION The chromatographic conditions in Chinese Pharmacopoeia are more suitable for residual solvents detection than US Pharmacopoeia. The control of residual solvents would be improved if medium polarity system is introduced into Chinese Pharmacopoeia.
关键词
药典 /
残留溶剂 /
气相色谱
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Key words
Pharmacopoeia /
residual solvent /
gas chromatography
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中图分类号：
R917
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参考文献
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