气相色谱法测定美沙拉嗪缓释颗粒三种有关物质的含量  

Determination of Three Kinds of Related Substance in Mesalazine Sustained Release Granules by Gas Chromatography

作　　者：张雪玲[1] 于晓秋[1] 张玥[2] 崔雪丹[2] 王超众 

机构地区：[1]齐齐哈尔医学院附属第二医院药剂科,齐齐哈尔161006 [2]黑龙江省齐齐哈尔市第一医院药剂科,齐齐哈尔161005 [3]黑龙江省齐齐哈尔市食品药品检验检测中心,齐齐哈尔161006

出　　处：《医药导报》2016年第2期184-187,共4页Herald of Medicine

摘　　要：目的建立气相色谱法测定美沙拉嗪缓释颗粒中苯胺、2-氨基苯酚、4．氨基苯酚三种有关物质的含量。方法采用安捷伦HP-5（10m×0．53mm，2．65μm）毛细管柱，载气为高纯氮气，流速15mL·min-1，氢火焰离子检测器（FID），进样口温度280℃，进样量4μL，检测器温度300℃，程序升温（起始温度70℃，保持2min，以10℃·min-1的速率升温至150℃，维持6min。结果3个杂质分离度良好。苯胺、2-氨基苯酚、4-氨基苯酚的回收率在98．04％-103．00％。精密度、线性回归等良好。结论该方法能用于美沙拉嗪缓释颗粒的质量控制。Objective To establish a gas chromatography （GC） method for determination of aniline, 2-aminophenol and 4-aminophenol in mesalazine sustained release granules. Methods Agilent HP-5 （ 10 m×0.53 mm, Z 65 μm） capillary GC column was adopted.The carrier gas was high purity nitrogen at a flow rate of 15 mL·min-1.The inlet temperature was controlled at 280 ℃ and the FID detector temperature was 300 ~C .The oven temperature was initially held at 70℃ for 2 min and was then programmed to 150℃ at 10℃ · min-1 and held for 6 rain. Results A good resolution was obtained between the peaks of the three impurities at chromatographic conditions above. The recoveries of aniline, 2-aminophenol and 4-aminophenol were among 98.04% to 103.00%.The precision and linearity equations were good. Conclusion The method can be adopted for the quality control of mesalazine sustained release granules.

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

分 类 号：R927.2[医药卫生—药学] R975