| 顶空毛细管气相色谱法测定二氟尼柳原料药中的残留溶剂 |
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| 引用本文： | 方凯,胡鸣韵,黄俊,李萍.顶空毛细管气相色谱法测定二氟尼柳原料药中的残留溶剂[J].化工生产与技术,2012,19(2):6-8,3. |
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| 作者姓名： | 方凯 胡鸣韵 黄俊 李萍 |
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| 作者单位： | 1. 巨化集团公司制药厂
2. 巨化集团技术中心,浙江衢州,324004 |
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| 摘 要： | 采用Agilent DB-624毛细管色谱柱（25 m×0.53 mm×3.0μm）,FID检测器,N,N-二甲基甲酰胺为溶剂,进行了顶空毛细管气相色谱法同时测定二氟尼柳原料药中二氯甲烷、苯及甲苯等3种残留溶剂的分析方法试验。结果表明,3种残留溶剂在各自的含量范围内呈良好的线性关系（相关系数0.994 5～0.997 5）,检测限分别为0.012 8、0.044 8、0.189 mg/L,平均添加回收率为90.6%～97.9%。所建方法简单、灵敏、可靠,适用于二氟尼柳原料药中残留溶剂的分析检测。
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| 关 键 词： | 气相色谱法 顶空采样 残留溶剂 二氟尼柳 |
Head-Space Sampling Capillary GC for Determing Residual Solvents in Raw Material Drug of Diflunisal |
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| Fang Kai,Hu Mingyun,Huang Jun,Li Ping.Head-Space Sampling Capillary GC for Determing Residual Solvents in Raw Material Drug of Diflunisal[J].Chemical Production and Technology,2012,19(2):6-8,3. |
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| Authors: | Fang Kai Hu Mingyun Huang Jun Li Ping |
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| Affiliation: | 1.Juhua Group Corporation Pharmaceutical Factory;2.Juhua Group Technology Center: Quzhou,Zhejiang 324000) |
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| Abstract: | A capillary GC method with head-space sampling was established for determing residual solvents such as dichloromethane,benzene and methylbenzene in raw material drug of Diflunisal.Agilent DB-624 capillary column(25 m×0.53 mm×3.0 μm) was used,FID as detector and DMF as the solvent.The result showed that linear responses were obtained for the 3 residual solvents in their respective concentration ranges(R=0.994 5~0.997 5,n=5).The average recoveries of three concentration levels were 90.6%~97.9%.The developed method simple,sensitive and accurate for the residual solvent analysis in raw material drug of Diflunisal. |
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| Keywords: | gas chromatography(GC) head-space sampling residual solvents Diflunisal |
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