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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-氨基苯酚等有关物质的含量。方法采用安捷伦HP-5(10 m×0.53 mm,2.65μm)毛细管柱,载气为高纯氮气,流速15 mL?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2 min,以10℃?min-1的速率升温至150℃,维持6 min 。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检测。“,”Objective To establish a gas chromatography ( GC) method for determination of aniline,2-aminophenol and 4-aminophenol in mesalamine sustained release granules. Methods An HP-5 (10 m×0.53 mm,2.65 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℃. 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 min. Results A good resolution was obtained between the peaks of the 3 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.