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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。
OBJECTIVE To establish a method for the simultaneous qualitative and quantitative determination of 10 residues of methanol, ethanol, acetone, isopropanol, n-hexane, ethyl acetate, benzene, 1,2-dichloroethane, n-butanol and divinylbenzene in solid food Solvent method. Methods Gas chromatography-FID detector was used. The column was DB-624 capillary column and GC-MS-EI ion source. The column was DB-624MS capillary column. Results The linear relationship between the organic solvents was good (r> 0.99). The average recoveries ranged from 85.2% to 108.6% with RSDs ranging from 1.0% to 3.1%. Conclusion The method is simple, accurate and sensitive. The detection limits are lower than those of organic solvents in Part IIP of the Second Edition of the Chinese Pharmacopoeia (2010). It is suitable for the simultaneous determination of residual organic solvents in health food solid preparations.