| 甲芬那酸中2,3-二甲基苯胺杂质限量控制方法的研究 |
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| 引用本文： | 刘敏,李玉兰. 甲芬那酸中2,3-二甲基苯胺杂质限量控制方法的研究[J]. 中国药事, 2009, 23(7): 672-675 |
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| 作者姓名： | 刘敏 李玉兰 |
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| 作者单位： | 广东省深圳市药品检验所,深圳,518029 |
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| 摘 要： | 目的比较了比色法、薄层色谱法、高效液相色谱法测定甲芬那酸中2,3-二甲基苯胺杂质的方法,并建立了毛细管气相色谱法控制甲芬那酸中2,3-二甲基苯胺的杂质限量。方法采用HP-INNOWAX毛细管色谱柱,柱温为150℃,进样口温度为220℃,检测器温度为230℃,载气为氮气,进样量为1μL（分流比10∶1）。结果2,3-二甲基苯胺的平均回收率为95.4%（n=9）,RSD为1.5%。结论本方法简便、快速,专属性强,适用于甲芬那酸中2,3-二甲基苯胺的杂质限量的控制。
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| 关 键 词： | 甲芬那酸 2,3-二甲基苯胺 杂质限量 GC |
Study on the Limited Control of 2,3-Dimethylaniline in Mefenamic Acid |
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| Liu Min,Li Yulan. Study on the Limited Control of 2,3-Dimethylaniline in Mefenamic Acid[J]. Chinese Pharmaceutical Affairs, 2009, 23(7): 672-675 |
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| Authors: | Liu Min Li Yulan |
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| Affiliation: | Liu Min and Li Yulan (Shenzhen City Institute for Drug Control, Shenzhen 518029) |
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| Abstract: | Objective To compare colorimetry, TLC, HPLC, and establish a methodfor the hmlted control of 2,3-dimethylaniline in mefenamic acid by GC with capillary column. Methods Using HP-INNOWAX column. The column temperature was 150℃, the injector temperature was 220℃ and the detector temperature was 230℃. The carrier gas was N2. The 1μL sample （ with split ratio of 10 ： 1） was injected into CA2. Results The average recovery of 2,3-dimethylaniline was 95.4 %（n= 9）, RSD=1.5 %. Conclusions The method appears to be simple, rapid and specificity. |
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| Keywords: | GC |
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