| 盐酸兰地洛尔中残留溶剂测定方法研究 |
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| 引用本文： | 李清涛,李明丽,史雪莲.盐酸兰地洛尔中残留溶剂测定方法研究[J].齐鲁药事,2010,29(2):92-94. |
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| 作者姓名： | 李清涛 李明丽 史雪莲 |
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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同时测定盐酸兰地洛尔中有机残留溶剂正己烷、丙酮、乙酸乙酯、甲醇、乙醇、二甲基亚砜的残留量.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220℃;进样口温度200℃;柱温度:程序升温,初始温度40℃,保持5min,再以20℃·min-1升温至180℃保持3min;载气:氮气.结果该色谱条件下,各组分分离良好,平均回收率99.44%与100.25%之间,RSD值在0.602%与0.699%之间.结论本方法准确、可靠,测定方法简单、快速、重现性好.
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| 关 键 词： | 盐酸兰地洛尔 气相色谱法 残留溶剂 |
Study on the test for solvent residues of Landiolol Hydrochloride |
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| LI Qing-tao,LI Ming-li,SHI Xue-lian.Study on the test for solvent residues of Landiolol Hydrochloride[J].qilu pharmaceutical affairs,2010,29(2):92-94. |
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| Authors: | LI Qing-tao LI Ming-li SHI Xue-lian |
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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 solvent residues of Landiolol Hydrochloride ineluding hexane,acetone,aletie ether,methanol,ethanol and DMSO. METHODS The solvent residues were determined by GC with PEG--20M column （30m）〈 0. 32mm, 0.50μm） with FID detector and nitrogen as the carries gas. The injector temperature was 200℃,the detector temperature was 220℃, the column temperature was increased by program, the initial temperature was 40℃ ,maintained for 5 minutes,raised to 180℃ with a rate of 20℃·min^-1 ,maintained for 3 minutes. RESULTS All components were completely separated by GC, average recoveries were from 99.44% to 100. 25%, RSD were from 0. 602% to 0. 699%. CONCLUSION The method of GC was accurate,simple,rapid,and producible. |
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| Keywords: | Landiolol hydrochloride GC solvent residues |
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