| 毛细管气相色谱法测定盐酸多塞平中有机溶剂的残留量 |
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| 引用本文： | 张晓玲,廖声华,严拯宇. 毛细管气相色谱法测定盐酸多塞平中有机溶剂的残留量[J]. 海峡药学, 2011, 23(9): 38-41 |
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| 作者姓名： | 张晓玲 廖声华 严拯宇 |
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| 作者单位： | 1. 中国药科大学分析化学教研室,南京,211198
2. 中国药科大学分析化学教研室,南京,211198;国家药物质量与安全预警教育部重点实验室,南京,211198 |
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| 摘 要： | 目的建立测定盐酸多塞平中有机残留溶剂的测定方法。方法采用100%聚二甲基硅氧烷毛细管柱（30.0m×320μm×0.4μm）;氢火焰离子化检测器（FID）;柱温采用程序升温：初温30℃（保持14min）,以30℃.min-1升温至85℃（保持2min）,以50℃.min-1升温至180℃（保持4min）;载气为N2,流速：起始为0.7mL.min-1（保持14min）,以1mL.min-1升到2mL.min-1（保持7.7min）;进样口温度：220℃;检测器温度：250℃。结果 7种残留溶剂达到完全分离,且均呈现良好的线性关系和回收率,3批样品检测残留溶剂均未超标。结论本测定方法简单,准确,可以用于盐酸多塞平原料药中残留溶剂的测定。
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| 关 键 词： | 气相色谱 甲醇 甲苯 乙醇 乙醚 乙酸乙酯 丙酮 石油醚 残留溶剂 盐酸多塞平 |
Determination of residual organic solvents in Doxepin Hydrochloride by capillary gas chromatography |
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| ZHANG Xiao-ling,LIAO Sheng-hua,YAN Zheng-yu. Determination of residual organic solvents in Doxepin Hydrochloride by capillary gas chromatography[J]. Strait Pharmaceutical Journal, 2011, 23(9): 38-41 |
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| Authors: | ZHANG Xiao-ling LIAO Sheng-hua YAN Zheng-yu |
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| Affiliation: | ZHANG Xiao-ling1,LIAO Sheng-hua1,YAN Zheng-yu1,2(1.Analysis Laboratory of China pharmaceutical university,Nanjiang 211198,China,2.Key Laboratory of Drug Quanlity Control and Pharmacovigliance of Ministry of Education,China) |
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| Abstract: | OBJECTIVE To eastablish a method for the determination of residual organic solvents in Doxepin Hydrochloride by capillary gas chromatography.METHODS The GC determination was performed on 100%Polydimethylsiloxane(30.0m×320μm×0.4μm)with FID detection.The injection port temperature was maintaining at 220℃ and the detector temperature was maintaining at 250℃.The initial column temperature was 30℃,maintaining it for 14min,then raising the temperature to 85℃ at the rate of 30℃/min,maintaining it for 2min,last raising the temperature to 180℃ at the rate of 50℃/min,maintaining it for 2min.N2 is the carry gas,the initial flow rate was 0.7mL·min-1,maintaining it for 14min,then raising the flow rate to 2mL·min-1 at the rate of 1mL·min-1,maintaining it for 7.7min.RESULTS Under experiment condition,seven residual organic solvents were separated thoroughly.Every solvents have good linear relationship and recovery.None of residual organic solvent was found to exceed quality limit.CONCLUSION The method is proved to be simple and accurate.It is suitable for determination of organic solvents in Doxepin Hydrochloride. |
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| Keywords: | Gas chromatography Methanol toluene Ethanol Diethyl ether Acetic ether Acetone Petroleum ether Doxepin hydrochloride |
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