明胶空心胶囊中有机溶剂残留量的分析方法研究  

Determination of residual organic solvents in vacant gelatin capsules

作　　者：朱小红 李涛 朱建荣 杜远东[2] 刘海静 杨智海 赵玉珍 

机构地区：[1]陕西省食品药品检验所,西安710061 [2]陕西中医学院,咸阳712046

出　　处：《药物分析杂志》2012年第8期1321-1324,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立顶空进样-气相色谱-质谱联用法(HS-GC-MS)初筛定性、顶空进样-气相色谱-氢火焰离子化检测器(HS-GC-FID)定量测定药用明胶空心胶囊中有机溶剂残留量的检测方法。方法:采用HS-GC-MS,Scan模式定性鉴别残留溶剂的种类。采用HS-GC-FID检测器,定量测定明胶空心胶囊中丙酮、乙醇、三氯甲烷和甲苯4种有机溶剂的残留量。结果:在选定的色谱条件下,4种有机溶剂达到了完全分离,在所考察范围内线性关系良好,样品中的有机溶剂残留量均在规定限度范围内。结论:该法快速,准确,专属性强,可用于明胶空心胶囊中有机溶剂残留量的控制。Objective：To establish HS-GC-MS and HS-GC-FID methods for determination of the residual organic solvents in vacant gelatin capsules.Method：HS-GC-MS Qualitative and screening mode was carried out.The 4 residual organic solvents including acetone,ethanol trichloromethane and toluene were determined by HS-GC-FIDinstrument coupled with headspace sampler in vacant gelatin capsules.Result：At the selected chromatographic conditions,4 kinds of residual organic solvents could get completely separation.The linear regression coefficients between peak areas and concentration were good.The contents of 4 kinds of residual organic solvents in sample were all in the limit range of define.Conclusion：This method is rapid,accurate,selective and suitable for determine the residual organic solvents in vacant gelatin capsules.

关 键 词：顶空进样-气相色谱-质谱 气相色谱 明胶空心胶囊 有机溶剂残留量 丙酮 乙醇 三氯甲烷 甲苯 

分 类 号：R917[医药卫生—药物分析学]