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大口径毛细管气相色谱检查药物中残留溶剂的方法研究

来源:中国色谱网
摘要: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。药物分析杂志,1......

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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 solventsSixteen organic solvents commonly used for pharmaceutical synthesis were analysedThe effects of different polarity columns and extraction solvents on the assay of residual solvents were studied in this workIt showed that most solvents can be well separated from each other on non-polar or less polar wide-bore columnsExtraction solvents differed in their extraction recovery and peak shapeSatisfactory results can be obtained when the proposed method was employed and a suitable extraction solvent was selectedThe procedures summarized in this paper can be used as a guidance for the evaluation of residual organic solvents in bulk pharmaceuticals
Keywordswide bore open tubular column; gas chromatography; residual solvents

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
[2]Ian D, David G. Analyst, 1991, 116(4):1 327-1 331
[3]WU Xiu-juan,SONG Yu-wen. Chinese Journal of Pharmaceutical Analysis,1992,12(1):54-55武秀娟,宋育文. 药物分析杂志,1992,12(1):54-55
[4]DOU Ai-lan, ZHONG Hua-ren, HAO Li-xiao. Chinese Journal of Pharmaceutical Analysis,1996,16(6):382-383窦爱兰,钟化人,郝丽晓. 药物分析杂志,1996,16(6):382-383
[5]Pascal B. J Chromatogr, 1992, 623(7): 305-313

 

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原载于《色谱》2001 Vol.19 No.2 P.141-143
http://periodical.wanfangdata.com.cn/periodical/sp/sp2001/0101/0101ml.htm

 
作者: 姚倩 李章万 张强 叶利民 2007-5-18
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