| 气相色谱法测定氯吡格雷中的溶剂残留 |
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| 引用本文： | 陈延祥,黄华珊,鲁凤莉,张娜.气相色谱法测定氯吡格雷中的溶剂残留[J].广东化工,2012(12):223-224. |
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| 作者姓名： | 陈延祥 黄华珊 鲁凤莉 张娜 |
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| 作者单位： | 山东大学药学院;淄博新达制药 |
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| 摘 要： | 建立气相色谱法测定氯吡格雷中的溶剂残留。以二甲亚砜为溶剂,采用顶空气相色谱法对甲醇、乙酸乙酯、四氢呋喃、环己烷进行研究。相对标准偏差为0.49%~1.8%,峰面积与浓度呈良好的线性关系,甲醇、乙酸乙酯、四氢呋喃、环己烷的定量限分别为20、5、3、2 ppm,检出限分别为8、2、1、1 ppm。本方法重现性好,专属性强,可用于氯吡格雷中的溶剂残留的测定。
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| 关 键 词： | 气相色谱 氯吡格雷 溶剂残留 |
Gas Chromatographic Determination of Residual Solvents in Clopidogre |
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| Chen Yanxiang,Huang Huashan,Lu Fengli,Zhang Na.Gas Chromatographic Determination of Residual Solvents in Clopidogre[J].Guangdong Chemical Industry,2012(12):223-224. |
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| Authors: | Chen Yanxiang Huang Huashan Lu Fengli Zhang Na |
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| Affiliation: | 1(1.School of Pharmaceutical Sciences,Shandong University,Jinan 250012;2.Zibo Xida Pharmacy,Zibo 255005,China) |
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| Abstract: | A method for determination of residual solvents in clopidogrel was established.The samples were dissolved in dimethyl sulfoxide.Headspace gas chromatography was used to determine the content of methanol,ethyl acetate,tetrahydrofuran and cyclohexane.The results showed that the linearity of peak area and concentration was good,with a relative deviation of 0.49 %~1.8 %.Limit of quantification were 20,5,3,2 and limit of detection were 8,2,1,1 of methanol,ethyl acetate,tetrahydrofuran and cyclohexane.The method with good reproducibility and specificity was suitable for the determination of residual solvents in clopidogrel. |
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| Keywords: | gas chromatography clopidogrel residual solvents |
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