气相色谱法测定阿德福韦酯中的10种残留溶剂  

GC Determination of 10 Kinds of Residual Solvents in Adefovir Dipivoxil

作　　者：张雅军[1] 孙会敏[1] 李科[2] 田颂九[1] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]第二军医大学药学院,上海200433

出　　处：《药物分析杂志》2005年第6期660-662,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:用毛细管柱气相色谱法建立10种残留溶剂的测定方法。方法:采用 HP-FFAP(50m×0.32mm×0.52μm)毛细管柱,以氮气为载气,FID 检测器,两次程序升温,分流直接进样,外标法计算残留溶剂的含量。结果:在浓度为20-1000μg·mL^(-1)范围内具有良好的线性关系(10种溶剂工作曲线的相关系数均为0.999以上),10种溶剂的3个不同浓度的平均回收率范围为85.3%-103.1%,RSD 为0.2%-7.4%。结论:本方法简便、结果准确、重现性好,可用于多种残留溶剂的同时测定。Objective:To establish a method for determining the residues of 10 kinds of solvents by capillary gas chromatography.Mehtod:The capillary column was HP-FFAP(50 m×0.32 mm×0.52μm).The carrier gas was nitrogen gas and FID was as detector.The injector temperature was 160℃ and the detector temperature was 250℃.The column temperature program was initial temperature 40℃,with the increase rate of 40℃·min^(-1) to 150℃(hold 15 min),40℃·min^(-1) to 240℃(hold 15 min).The assay of residual solvents were calculated by external standard method.Results:Under this condition,there is good linear relationship in the concentration range of 20-1000g·mL^(-1),the average recoveries and RSD ranged from 85.3% to 103.1% and 0.2% to 7.4% ,re- spectively.Conclusion:The method is easy and has good separation and repeatability.

关 键 词：残留溶剂 气相色谱法测定 阿德福韦酯 毛细管柱气相色谱法 平均回收率 测定方法 程序升温 直接进样 相关系数 工作曲线 线性关系 不同浓度 同时测定 检测器 外标法 RSD 重现性 

分 类 号：R155.58[医药卫生—营养与食品卫生学] R134[医药卫生—公共卫生与预防医学]