明胶空心胶囊中有机溶剂残留量的分析方法研究

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。

Determination of residual organic solvents in vacant gelatin capsules

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.