保健品固体制剂中10种残留溶剂GC分析及GC-MS确证

Determination of 10 Kinds of Residual Organic Solvents in Health Food Solid Preparations by GC and Its Confirmation by GC-MS

摘要: 目的建立可同时定性定量检测保健食品固体制剂中甲醇、乙醇、丙酮、异丙醇、正己烷、乙酸乙酯、苯、1,2-二氯乙烷、正丁醇、二乙烯苯10种残留溶剂的方法。方法气相色谱-FID检测器，色谱柱为DB-624毛细管色谱柱；GC-MS-EI离子源，色谱柱为DB-624MS毛细管色谱柱。结果各有机溶剂线性关系良好(r>0.99)，平均回收率为85.2%~108.6%，RSD为1.0%~3.1%。结论本方法简便准确、灵敏度高，检出限都低于中国药典2010年版二部附录ⅧP中有机溶剂允许残留量的要求，适用于保健食品固体制剂中有机溶剂残留量的同时测定。

Abstract: OBJECTIVE To establish a method for analysis of methanol, ethanol, acetone, isopropanol, n-hexane, ethyl acetate, benzene, 1,2-dichloroethane, n-butanol, and divinylbenzene in health food. METHODS A GC method with FID detector and DB-624 capillary column, and a GC-MS method with DB-624MS capillary column and EI ion-source had been established. RESULTS The calibration curves for the residual organic solvents were linear with r>0.99. The assay recoveries ranged in 85.2%-108.6% and the RSD was 1.0%-3.1%. CONCLUSION The detection limits of the method were lower than the residual organic solvents limits of Ch.P 2010 Ⅱ Appendix Ⅷ P. The method established can be used to detect 10 kinds of residual organic solvents in health food solid preparations.