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

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一624毛细管柱（0．53mm×30m，3．0μm）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0．9999～1．0000，平均回收率为99．3％～101．5％，精密度RSD均〈10％，最低检出限为0．173～0．396μg·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。

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 200 ℃. FID was used as detector with a temperature of 250 ℃. 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.