目的：采用气相色谱法测定卤米松原料药中甲醇、乙醇、乙腈的残留量。方法：采用Agilent DB-624型毛细管色谱柱（50.0m×0.32mm×0.5μm）；以N，N-二甲基甲酰胺（DMF）为溶剂；柱温为50℃，保持7min，以40℃﹒min-1升温至200℃，保持6min；进样口温度为200℃，进样量1μL；检测器为FID，温度为220℃；载气为N2，流速为1mL﹒min-1。结果：甲醇、乙醇、乙腈在检测浓度范围内线性关系良好，相关系数均大于0.999；平均回收率为103.42%、100.90%、103.98%，RSD均小于2%；检测限分别为1.26μg﹒mL-1、0.65μg﹒mL-1、0.374μg﹒mL-1。结论：本法操作简便、结果准确，可用于测定卤米松原料药中甲醇、乙醇、乙腈的残留量。
Determination of Residual
Organic Solvents in raw material medicine of Halometasone by GC
ZHOU Fang1, LI Zhao-guang2,
LIU Yun-feng2（1.Jiangsu Agri-animal
Husbandry Vocational College, taizhou 225300; 2.Jiangsu Jibeier Pharmaceutical Joint Stock Limited Liability Company, Zhenjiang
212009）
Abstract：Objective
To establish a GC method to determine methanol, ethanol
and acetonitrile residual solvents in raw material medicine of Halometasone. Methods The capillary column was Agilent DB-624 (50.0
m×0.32 mm×0.5μm); DMF
was used as the solvent; the initial temperature was programmed at 50℃, maintained for 7 min, raised to 200℃
with 40℃﹒min-1,
then maintained for another 6 min.; the inlet temperature was 200℃,the injection volume
was 1μL;
detector was FID with the temperature of 220℃; the carrier gas was N2
with the flow rate of 1mL﹒min-1.
Results The methanol, ethanol and acetonitrile
had good linear relationships in their respective concentration ranges, the
correlation coefficient was more than 0.999;
the average recoveries were 103.42%,100.90%,103.98% respectively, RSDs were all
less than 2%; the detection limits were 1.26μg﹒mL-1,
0.65μg﹒mL-1, 0.374μg﹒mL-1 respectively. Conclusion
This method is simple and accurate, can be used for the determination of
residual methanol, ethanol
and acetonitrile in Halometasone raw material medicine.
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