| 引用本文: | 郑金琪,岑予欣,付利娜,何婷婷,陶巧凤.顶空毛细管气相色谱法测定本芴醇中多种残留溶剂[J].中国现代应用药学,2014,31(12):1500-1502. |
| ZHENG Jinqi,CEN Yuxin,FU Lina,HE Tingting,TAO Qiaofeng.Determination of Residual Oganic Solvents in Lumefantrine by Headspace Capillary Gas Chromatography[J].Chin J Mod Appl Pharm(中国现代应用药学),2014,31(12):1500-1502. |
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| 摘要: |
| 目的 建立测定本芴醇原料药中残留溶剂的顶空毛细管气相色谱法。方法 以DB-624毛细管柱(0.53 mm×30 m，3.0 μm)为色谱柱，氮气为载气，用FID检测器，测定本芴醇原料药中甲醇、乙醇、乙酸乙酯、甲苯、异丙醇和丙酮的残留量(外标法计算)。结果 6种有机溶剂完全分离，浓度在考察范围内与峰面积具有良好的线性关系，r为0.999 9~1.000 0，平均回收率为99.3%~101.5%，精密度RSD均<10%，最低检出限为0.173~0.396 μg·mL-1。结论 本法快速、灵敏、准确，能较好地检测本芴醇原料药中有机溶剂残留量，控制产品质量。 |
| 关键词: 本芴醇 残留溶剂 毛细管气相色谱 顶空进样 |
| DOI： |
| 分类号:R917.101 |
| 基金项目:国家药典委员会全球基金项目(GF2012-45) |
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| Determination of Residual Oganic Solvents in Lumefantrine by Headspace Capillary Gas Chromatography |
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ZHENG Jinqi1, CEN Yuxin2, FU Lina3, HE Tingting1, TAO Qiaofeng1
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1.Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China;2.College of Pharmaceutical, China Pharmacertical University, Nanjing 210009, China;3.College of Pharmaceutical, Zhejiang University of Technology, Hangzhou 310014, China
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| Abstract: |
| OBJECTIVE To establish a method of head-space capillary gas chromatography(GC) for the determination of residual organic solvents in lumefantrine. METHODS Residual organic solvents in lumefantrine were separated on DB-624 capillary column using temperature programming and nitrogen as the carrier gas. The inlet temperature was 250 ℃. FID was used as detector with a temperature of 200 ℃. RESULTS Six residual organic solvents were completely separated. There was a good linearity in the experimental concentration ranges(r=0.999 9-1.000 0). The RSD of precision was less than 10%. The average recovery rate ranged from 99.3% to 101.5%. The detection limits were between 0.173 and 0.396 μg·mL-1. CONCLUSION The method is rapid, sensitive and accurate, which can be used for quality control for the determination of residual organic solvents in lumefantrine. |
| Key words: lumefantrine residual solvents capillary gas chromatography headspace injection |
