GC法同时测定美沙拉嗪原料药中3种有关物质的含量  

GC Simultaneous Determination of Related Substances in Mesalazine

作　　者：贾首时 任曼妮 

机构地区：[1]齐齐哈尔市食品药品检验检测中心,齐齐哈尔161006

出　　处：《中国药品标准》2015年第4期260-263,共4页Drug Standards of China

摘　　要：目的:建立同时测定美沙拉嗪原料药中苯胺、2-氨基苯酚、4-氨基苯酚3种有关物质含量的方法。方法:采用气相色谱法,HP-5(10 m×0.53 mm×2.65μm)毛细管柱,氢火焰离子检测器(FID),程序升温(起始温度70℃,保持2 min,以15℃·min-1的速率升温至150℃,维持2 min),载气为高纯氮气,进样口温度280℃,检测器温度300℃。结果:3种杂质能有效分离,精密度、回收率、线性回归等良好。结论:本方法可用于美沙拉嗪原料药的质量控制。Objective： To establish a GC method for simultaneous determination of aniline, 2-amino phenol and 4-amino phenol in Mesalazine, nethods：GC method was adopted,the determination was performed on a HP-5 capillary column （10 m × 0. 53 mm× 2. 65 μm）. The column temperature was programmed （maintained at 70 ℃ for 2 min, then risen to 150 ℃ at the rate of 15 ℃ · min-1, held for 2 min）. The carrier gas was high purity nitrogen. The FID was used as detector, the temperatures of the injector and the detector were set at 280 ℃ and 300 ℃. Results ： A good resolution was obtained among 3 impurity peaks. The precision, recovery and line-rity equation were pretty well. Conclusion： The method can be operated for the quality control of Mesalazine.

关 键 词：美沙拉嗪 气相色谱法 苯胺 2-氨基苯酚 4-氨基苯酚 有关物质 质量控制 

分 类 号：R95[医药卫生—药学]