吹扫捕集-GC-MS/SIM方法检测阿莫西林中的溶剂残留  

Determination of residual solvents in amoxicillin by purge & trap preconcentration and GC-MS/SIM selected ion monitoring

作　　者：吴婷[1] 杨凌[2] 王新明[1] 

机构地区：[1]中国科学院广州地球化学研究所有机地球化学国家重点实验室,广州510640 [2]南方医院药学部,广州510515

出　　处：《药物分析杂志》2007年第3期406-408,共3页Chinese Journal of Pharmaceutical Analysis

基　　金：国家自然科学基金(40203011);广东省自然科学基金团队基金(20003046)资助。

摘　　要：目的:建立阿莫西林中甲基异丁基酮和醋酸丁酯2种挥发性有机溶剂的残留量测定方法。方法:采用用吹扫捕集浓缩仪和色谱-质谱联用(SIM)(P&T-GC-MS/SIM)方法测定阿莫西林中甲基异丁基酮和醋酸丁酯2种挥发性有机溶剂的残留量。结果:吹扫管中2种溶剂量在0～3200 ng 范围内线性关系良好(r>0.99);吹扫管中2种溶剂量均为2400 ng 时,平行测定5次相对标准偏差分别为4.75%和0.66%;甲基异丁基酮和醋酸丁酯的检测限分别为2.9和4.8 ng。结论:方法能满足粉状和液体药品中 ng 至μg级残留溶剂的测定。Objective：To develop a reliable method for the determination of two residual solvents, methyl isobutyl ketone（MIBK） and butyl acetate （BA）in Amoxicillin. Method：A purge and trap preconcentrator coupled with gas chromatography - mass spectrometry in SIM mode was used for the determination of two residual solvents, MIBK and BA, in Amoxicillin. Result：Good linear responses were observed for both MIBK and BA in the range of 0 -3200 ng （r 〉0. 99）. The relative standard deviation（n =5）were 4. 75%and 0.66% for MIBK and BA at the level of 2400 ng. The limits of detection were about 2. 9 ng and 4. 8 ng for both MIBK and BA. Conclusion：The method can be applied to the analysis of residual solvents in medicines as liquids and powders.

关 键 词：药品溶剂残留 阿莫西林 甲基异丁基酮 醋酸丁酯 吹扫/捕集 气相色谱-质谱 

分 类 号：R917[医药卫生—药物分析学]