毛细管气相色谱法测定蒿甲醚中有机溶剂残留量  

Capillary Gas Chromatographic Determination of Residual Organic Volatile Solvent in Artemether

作　　者：鲍光明[1] 蒋晓慧[1] 田敏卿[2] 马亚平 袁厚群 白振锋[1] 

机构地区：[1]西华师范大学化学化工学院,四川南充637002 [2]中国科学院海洋研究所,青岛266071 [3]深圳翰宇生物工程有限公司广东省多肽药物工程技术研究开发中心,广东深圳518057 [4]丰桥技术科学大学物质工学系

出　　处：《西华师范大学学报（自然科学版）》2007年第2期207-209,218,共4页Journal of China West Normal University(Natural Sciences)

摘　　要：建立了用毛细管气相色谱法快速测定蒿甲醚中残留有机溶剂甲醇的方法.该方法采用直接进样法,聚乙二醇极性毛细管色谱柱,火焰离子化检测器(FID),以二甲基亚砜为溶剂,柱温为150℃,进样口的温度为200℃,检测器温度为250℃,载气为氮气;外标法计算甲醇残留量.经方法学验证,本方法检测甲醇专属性良好;在157.6-788.0μg.mL-1范围内呈良好线性(γ=0.9998)关系;精密度RSD为2.82%;最低检测限为6.2μg.mL-1;三批样品中有机溶剂甲醇残留量均符合ICH和中国药典2005午(第二部)要求.此方法灵敏、准确、可靠,适用于本品有机溶剂甲醇残留量的检测.We have established a method for determination of residual volatile organic solvent： methanol in artemether. Sample was dissolved in dimethyl sulfoxide and residual solvent： methanol was quantitatively determined by direct injection GC on PEG-20M capillary column which column temperatures was 150℃ ;Detector： FID detector; Carries gas： nitrogen. The injector and detector temperatures were 200℃ and 250℃ respectively. The residual level of methanol was determined by external standard method. The validation of analytical method was performed. Here shows excellent linearity between 157.6 - 788.0μg· mL^-1 （γ=0. 9998）. The RSD of precision was 2.82 %. The limit of detection was 6.2μg· mL^-1. The residual level of methanol in three batches of samples was complied with the ICH and ChP requirements. The method was proved to be accurate,sensitive and reliable by validation. It was suitable to be adopted in the analysis of the tested solvent.

关 键 词：气相色谱 蒿甲醚 甲醇 有机溶剂残留 

分 类 号：R917[医药卫生—药物分析学]