气相色谱法测定阿克他利中的有机溶剂残留量  

Determination of residual organic solvents in actarit by capillary gas chromatography

作　　者：兰静[1] 

机构地区：[1]天津市药品审评中心,天津300191

出　　处：《天津药学》2011年第2期16-18,共3页Tianjin Pharmacy

摘　　要：目的:建立毛细管气相色谱法测定阿克他利中的有机溶剂残留量。方法:采用HP-FFAP毛细管气相色谱柱,FID检测器,以正丙醇为内标进行测定。结果:乙醇、醋酸、DMF的线性范围分别为50～800μg/ml(r=0.999 9)、50～800μg/ml(r=0.999 7)和8.8～140.8μg/ml(r=0.999 9);乙醇、醋酸、DMF的平均回收率分别为100.7%、100.2%和99.7%;RSD分别为0.87%、1.32%和1.47%(n=9)。结论:该方法简单、灵敏、准确、重现性好,适用于阿克他利中的有机溶剂残留量的测定。Objective：To develop a gas chromatography method for the determination of residual organic solvents in actarit.Methods： The samples were injected into HP-FFAP capillary column and analyzed with FID detector using n-propanol as the internal standard.Results：The linear ranges of ethanol,acetic acid,DMF were 50～800 mg/L（r=0.999 9）,50～800 mg/L（r=0.999 7） and 8.8～140.8 mg/L（r=0.999 9）,respectively.The recoveries were 100.7%,100.2 % and 99.7 %,respectively;RSDs were 0.87 %,1.32 % and 1.47 %（n=9）,respectively.Conclusion：The method is simple,accurate and sensitive with good reproducibility,and can be used for the determination of the residual organic solvents in actarit.

关 键 词：阿克他利 毛细管气相色谱法 有机溶剂 残留量 

分 类 号：R927.11[医药卫生—药学]