硫酸氢氯吡格雷中有机溶剂残留量的顶空毛细管气相色谱法测定 |
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引用本文: | 田勇,唐素芳.硫酸氢氯吡格雷中有机溶剂残留量的顶空毛细管气相色谱法测定[J].中国医药工业杂志,2012,43(2):134-136. |
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作者姓名: | 田勇 唐素芳 |
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作者单位: | 天津市药品检验所,天津,300070 |
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摘 要: | 建立了顶空毛细管气相色谱法测定硫酸氢氯吡格雷中的甲醇、丙酮、异丙醇、二氯甲烷、异丙醚与乙酸乙酯.样品采用氧化镁进行预处理,采用DB-624毛细管色谱柱,程序升温,FID检测器,顶空平衡温度70℃,平衡时间30 min.上述溶剂分别在7.5~750、5~500、12.5~1 250、1.5~150、12.5~1 250和12.5~1 250μg/ml浓度范围内线性关系良好,回收率分别为100.4%、101.2%、100.5%、98.2%、99.2%和99.6%,RSD均小于2.0%.
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关 键 词: | 硫酸氢氯吡格雷 有机溶剂残留 顶空毛细管气相色谱 测定 |
Determination of Residual Organic Solvents in Clopidogrel Hydrogen Sulfate by Headspace Capillary Gas Chromatography |
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Authors: | TIAN Yong TANG Sufang |
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Institution: | (Tianjin Institute for Drug Control,Tianjin 300070) |
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Abstract: | A headspace capillary gas chromatography method was established for the determination of methanol,acetone,isopropanol,dichlormethane,isopropyl ether and ethyl acetate in clopidogrel hydrogen sulfate.The samples were pre-treated with magnesium oxide.A DB-624 capillary column was used with temperature program and FID detector,at injection temperature of 70 ℃ and equilibrium time of 30 min.The calibration curves of these solvents were linear in the concentration ranges of 7.5-750,5-500,12.5-1 250,1.5-150,12.5-1 250 and 12.5-1 250 μg/ml,respectively.The recoveries were 100.4%,101.2%,100.5%,98.2%,99.2% and 99.6%,with RSDs less than 2.0%. |
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Keywords: | clopidogrel hydrogen sulfate residual organic solvent headspace capillary gas chromatography determination |
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