| 气相色谱法测定聚山梨酯80中二甘醇的含量 |
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| 引用本文： | 史雪莲,王绍同,刘同欣.气相色谱法测定聚山梨酯80中二甘醇的含量[J].齐鲁药事,2010,29(2):88-90. |
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| 作者姓名： | 史雪莲 王绍同 刘同欣 |
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| 作者单位： | 1. 山东大学药学院,山东,济南,250012
2. 山东鲁抗展欣药业有限公司,山东,济宁,272031 |
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| 摘 要： | 目的建立一种气相色谱法测定聚山梨酯80中二甘醇的含量.方法色谱柱:以聚乙二醇(PEG-20M)为固定液的极性毛细管柱(30m×0.32mm,0.50μm);检测器:氢火焰离子检测器(FID);检测器温度230℃;进样口温度200℃;柱温度:程序升温,初始温度60℃,保持3min,再以10℃·min-1升温至230℃保持10min;载气:高纯氮气.结果二甘醇线性范围为0.025～0.25mg·mL-1(r=0.9993);平均回收率101.57%(RSD=1.505%,n=5).结论本方法简单、结果准确、重现性好,可用于聚山梨酯80中二甘醇含量的测定.
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| 关 键 词： | 聚山梨酯80 二甘醇 气相色谱法 |
Determination of diethylene glycol in Polysorbate-80 by Gas Chromatography |
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| SHI Xue-lian,WANG Shao-tong,LIU Tong-xin.Determination of diethylene glycol in Polysorbate-80 by Gas Chromatography[J].qilu pharmaceutical affairs,2010,29(2):88-90. |
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| Authors: | SHI Xue-lian WANG Shao-tong LIU Tong-xin |
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| Institution: | (School of Pharmaceutical Sciences,Shandong. University,Ji＇nan 250012;1. Shandong Lukang Cisen Pharmaceutical Limited Company,Jining 272031) |
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| Abstract: | OBJECTIVE To establish a GC method for the determination of diethylene glycol in Polysorbate- 80. METHODS The content was analyzed by GC with PEG--20M column （30m× 0. 32mm,0. 50μm） with FID detector and nitrogen as the carrier gas. The injector temperature was 200℃, the detector temperature was 230℃, the column temperature was increased by program, the initial temperature was 60℃ ,maintained for 3 minutes,raised to 230℃with a rate of 10℃ ·min^-1 , maintained for 10 minutes. RESULTS The linear range was from 0. 025 to 0. 25mg · mL^-1 （ r =0. 999 3）. The average recovery was 101.57% （ RSD = 1. 505%, n = 5）. CONCLUSION The method of GC was simple, sensitive and accurate. It can be used for the detection of diethylene glycol in polysorbate--80. |
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| Keywords: | Polysorbate-80 diethylene glycol GC |
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