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摘 要:以药物合成中常用的16种有机溶剂为研究对象,建立了用大口径毛细管柱检查残留有机溶剂的气相色谱法,并考察了不同极性的色谱柱及不同提取溶剂对分离与检测的影响。实验表明,根据原料药合成中可能存在的残留溶剂,选用适当的提取溶剂,采用大口径毛细管气相色谱法检查,可获得较满意的结果。
Abstract:A
GC method using wide bore open tubular columns was developed to evaluate
residual organic solvents. Sixteen
organic solvents commonly used for pharmaceutical synthesis were
analysed.The
effects of different polarity columns and extraction solvents on the
assay of residual solvents were studied in this work.
It showed that most
solvents can be well separated from each other on non-polar or less
polar wide-bore columns. Extraction
solvents differed in their extraction recovery and peak shape.
Satisfactory results can be
obtained when the proposed method was employed and a suitable extraction
solvent was selected.The
procedures summarized in this paper can be used as a guidance for the
evaluation of residual organic solvents in bulk pharmaceuticals. |
作者简介:姚倩(1971-),女,硕士,现工作单位为深圳海王生物工程股份有限公司。 作者单位:姚倩(华西医科大学药学院,四川成都 610041) 李章万(华西医科大学药学院,四川成都 610041) 张强(华西医科大学药学院,四川成都 610041) 叶利民(华西医科大学药学院,四川成都 610041) 参考文献: [1]LI Wei-yong,CAI Yu-yun,ZHAO
Shi-ying,et al. Chinese Journal of Pharmaceutical Analysis,1985,5(4):245-247李维庸,蔡玉云,赵士英,等.
药物分析杂志,1985,5(4):245-247 |
原载于《色谱》2001 Vol.19 No.2
P.141-143
http://periodical.wanfangdata.com.cn/periodical/sp/sp2001/0101/0101ml.htm