欧嘉娜
OU Jiana

• 1:广州市药品检验所

摘要(Abstract)：

目的采用顶空气相色谱法测定富马酸福莫特罗中有机溶剂残留量。方法用DB-624毛细管柱(30 m×0.25 mm,1.4μm),柱温为起始温度32℃,维持12 min,再以每分钟20℃的速率升温至215℃,维持9 min;进样口温度为140℃;氢火焰离子化检测器(FID);检测器温度为280℃。结果 7种溶剂的分离度良好,在所考察的质量浓度范围内线性关系良好,平均回收率为99.7%~103.4%,检出限为0.429 6~14.388 6μg/m L。结论所用方法简单,灵敏度高,可用于富马酸福莫特罗中有机溶剂残留量的限度检查。
OBJECTIVE To determine the residual solvent in Formoterol Fumarate Dihydrate by the headspace gas chromatography( GC) method. METHODS The DB-624 capillary column( 30 m × 0. 25 mm,1. 4 μm) was adopted; the initial temperature was 32 ℃,maintained for 12 min,then heated up to 215 ℃ with the rate of 20 ℃ / min,and maintained for 9 min; the injector port temperature was 140 ℃; the FID detector temperature was at 280 ℃. RESULTS Several solvents had the good separation degrees and good linear relations during the investigated concentration range. The average recovery rate was 99. 7%- 103.4%. The detection limit was 0. 429 6- 14. 388 6 μg / m L. CONCLUSION The used method is simple with high sensitivity and can be applied to the limit test of residual organic solvent in formoterol fumarate dehydrate.

关键词(KeyWords)： 富马酸福莫特罗;有机溶剂残留量;顶空气相色谱法
formoterol fumarate dehydrate;residual solvent;headspace gas chromatography

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作者(Author): 欧嘉娜
OU Jiana

参考文献(References)：

• [1]国家药典委员会.中华人民共和国药典[M].二部.北京:中国医药科技出版社,2010:附录61.