毛细管气相色谱法测定注射用利培酮微球中有机溶剂残留量  

Determination of Residual Amount of Organic Solvents in Risperidone for Depot Suspension by Capillary Gas Chromatography

作　　者：马建芳[1] 朱瀛华[1] 任飞亮[1] 刘蔚[1] 彭兴盛[1] 陈桂良[1] 

机构地区：[1]上海市食品药品检验所,上海200131

出　　处：《中国药业》2015年第12期69-71,共3页China Pharmaceuticals

摘　　要：目的建立同时测定注射用利培酮微球中残留有机溶剂乙醇、乙酸乙酯和苯甲醇的毛细管气相色谱法。方法采用DB-624毛细管色谱柱,直接进样,进样量为3μL,进样口温度为220℃,程序升温,氢火焰离子化检测器（FID）,检测器温度为250℃,载气为氦气,载气流速为1 m L/min,同时测定注射用利培酮微球中乙醇、乙酸乙酯和苯甲醇的有机溶剂残留量。结果乙醇和乙酸乙酯以乙酸丙酯为内标,苯甲醇以苯乙醇为内标,上述有机溶剂均得到有效分离,线性关系良好,相关系数均大于0.999,回收率均在90%~110%之间。结论该方法操作简单、灵敏度高、重复性好、专属性强、快速准确,适用于注射用利培酮微球中残留溶剂的含量测定。Objective To establish a capillary gas chromatography method for the simultaneous determination of residual organic solvents including ethanol,ethyl acetate and benzyl methanol in Risperidone for Depot Suspension. Methods The DB-624 capillary chromato-graphic column was used with direct injection and the temperature program. The volume of injection was 3 μL. The inlet temperature was 220 ℃. FID was used as the detector with the temperature of 250 ℃. The carrier gas was helium and its flow rate was 1 mL/min. The residual amounts of organic solvents including ethanol,ethyl acetate and benzyl methanol in Risperidone for Depot Suspension were simultaneously detected. Results Ethyl acetate was taken as the internal standard for ethanol and ethyl acetate,and benzyl ethanol as the internal standard for benzyl methanol. The organic solvents mentioned above were completely separated. The linear relations were good with the correlation coefficients exceeding 0. 999. The recovery rates were 90% -110%. Conclusion The method is simple,highly sensitive,better reproducible,strongly specific,rapid and accurate,which is suitable for the determination of residual organic solvents in Risperidone for Depot Suspension.

关 键 词：注射用利培酮微球 有机溶剂残留 毛细管气相色谱法 

分 类 号：R927.11[医药卫生—药学] R971.43