顶空毛细管气相色谱法测定富马酸阿奇霉素中的残留溶剂  

CGC determination of residual solvents in azithromycin fumarate

作　　者：王国兰[1] 寇晋萍[1] 王俊秋[1] 周立春[1] 余立[1] 

机构地区：[1]北京市药品检验所,北京100035

出　　处：《中国抗生素杂志》2013年第8期606-608,共3页Chinese Journal of Antibiotics

摘　　要：目的建立毛细管气相色谱方法测定富马酸阿奇霉素中的残留溶剂。方法采用气相色谱法测定,色谱柱为:DB-5(5%苯基-95%二甲基硅氧烷固定液)石英毛细管柱(Agilent 60m×0.320mm×1.00μm),载气为氮气;柱温为60℃;FID检测器温度为250℃;进样口温度为200℃;顶空瓶平衡温度55℃,平衡时间30min。结果被测物均能得到良好的分离,峰面积与浓度呈良好的线性关系,精密度与回收率良好。结论该法可用于富马酸阿奇霉素原料中残留溶剂的检查。Objective To establish a method of headspace capillary gas chromatography（CGC） for determination the residual solvents in azithromycin fumarate. Methods The residual solvents in azithromycin fumarate were separated by DB-5 capillary column（Agilent 60m×0.320mm× 1.00μm） with an FID detection. The carried gas was nitrogen. The column temperature was 60℃. The injector temperature and the detector temperature was controlled at 200℃ and 250℃, respectively. The containers of headspace injector were in equilibrium at 55 ℃ for 30min. Results The measured solvents were separated completely. The calibration curve of each solvent showed a good linear relationship with good precision and accuracy. Conclusion The established method was accurate and reliable. It can be used for the determination of residual solvent in azithromycin fumarate.

关 键 词：富马酸阿奇霉素 残留溶剂 毛细管气相色谱 

分 类 号：R978.15[医药卫生—药品]