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    顶空毛细管气相色谱法测定本芴醇中多种残留溶剂

    Determination of Residual Oganic Solvents in Lumefantrine by Headspace Capillary Gas Chromatography

      摘要
    • 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。

       

      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.

       

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