顶空毛细管气相色谱法测定溴化甲基纳曲酮中的残留溶剂  

Determination of residual organic solvents in methylnaltrexone bromide by GC

作　　者：刘文欣[1] 陈思明[2] 徐海燕[2] 袁波[2] 

机构地区：[1]沈阳巴斯夫维生素有限公司,沈阳110016 [2]沈阳药科大学,沈阳110016

出　　处：《西北药学杂志》2012年第2期116-118,共3页Northwest Pharmaceutical Journal

摘　　要：目的建立溴化甲基纳曲酮中有机残留溶剂的顶空毛细管气相色谱测定法。方法使用PEG-20M毛细管色谱柱(30m×0.25mm×0.25μm)进行分离;检测器为FID;进样口温度为200℃;检测器温度为250℃;柱温为35℃;顶空进样,80℃平衡40min;双蒸水为溶剂。结果有机残留溶剂能得到很好的分离,线性关系和精密度良好,平均回收率为95.1%～101.6%。结论该方法简单、准确、可靠,可用于溴化甲基纳曲酮中的残留溶剂的测定。Objective To develop a method of head-space capillary gas chromatography for the determination of residual organic sol- vents in methylnaltrexone bromide. Methods Residual organic solvents in methylnaltrexone bromide were separated by a PEG-20M capillary column （30 mX 0.25 mm × 0.25 μm） with a FID detector. The injector temperature and the detector temperature were controlled at 200 ℃ and 250 ℃, respectively. The column temperature was 35 ℃. The containers of head-space were in equilibrium at 80 ℃ for 40 min and the sample was dissolved in water. Results The measured solvents were separated completely. The calibra- tion curves of each solvent showed good linear relationship with good precision and accuracy. The average recoveries were between 95.1%-101.6%. Conclusion The method is simple,accurate and reliable,and can be used for the determination of the residual or- ganic solvents in methylnaltrexone bromide.

关 键 词：顶空毛细管气相色谱法 有机残留溶剂 甲基纳曲酮 溴化 测定 毛细管色谱柱 平均回收率 线性关系 

分 类 号：R927[医药卫生—药学]