顶空气相色谱法测定氨磷汀的残留溶剂  

Determination of Residual Organic Solvents in Amifostine by Headspace GC

作　　者：高睿 刘慧颖 王福鑫 GAO Rui;LIU Huiying;WANG Fuxin(Liaoning Institute for Drug Control,Shenyang 110036,China)

机构地区：[1]辽宁省药品检验检测院,辽宁沈阳110036

出　　处：《品牌与标准化》2023年第2期119-121,共3页

基　　金：辽宁省自然基金资助计划(2019-MS-185)。

摘　　要：目的:建立氨磷汀中甲醇、乙醇有机残留的检测方法。方法:采用DB-1301毛细管柱(30 m×0.32 mm,0.25μm),FID检测器,进行测定。结果:甲醇和乙醇的线性范围分别为2.994~598.9μg·mL^(1)(r=0.9997)和4.997~999.4μg·mL^(-1)(r=0.9998)(n=6);平均回收率分别为101.66%(RSD:1.65%)、104.9%(RSD%:1.38%)(n=9);检测限(LOD)分别为:0.07486μg·mL^(-1),0.1249μg·mL^(-1)。结论:采用此方法,可便捷、准确的检验氨磷汀中残留溶剂的检测。Objective:To establish a headspace gas chromatography method for the determination of residual solvents in Amifostine.Methods:A headspace gas chromatography was used with a capillary column DB-1301(30 mx0.32 mm,0.25μm),and with nitrogen as the carrier and an FID as the detector.Results:The linear range for methanol,ethanol was 2.994~598.9μg'mL^(-1)(r-0.9991),4.997~999.4μg mL^(-1)(r=0.9997)(n=7),respectively.The average recovery was 101.66%(RSD:1.65%)、104.9%(RSD%:1.38%)(n=9),and the LOD were 0.07486μg'mL",0.1249μg'mL^(-1),respectively.Conclusion:It is a simple,accurate method,can be used for the determination of various residual solvents in Amifostine.

关 键 词：氨磷汀 顶空气相色谱法 残留溶剂 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.71[化学工程—制药化工]