顶空气相色谱法测定阻隔性保护袋的残留溶剂  

Determination of Residual Organic Solvents in Barrier Protective Bag by Headspace Gas Chromatography

作　　者：谢春燕 谭南奇 黄灿中 岳峰 XIE Chunyan;TAN Nanqi;HUANG Canzhong;YUE Feng(Guangdong Jiabo Pharmaceutical Co. Ltd., Qingyuan,Guangdong 511517, China;Guangdong Engineering Center of Intravenous Lipid Emulsion^Qingyuan ,Guangdong 511517, China)

机构地区：[1]广东嘉博制药有限公司,广东清远511517 [2]广东静脉脂肪乳工程中心,广东清远511517

出　　处：《今日药学》2019年第8期526-530,共5页Pharmacy Today

基　　金：清远市创新创业团队专项资助(2016002);广东扬帆计划引进创业团队项目资助(2017YT05S029)

摘　　要：目的建立顶空气相色谱法测定阻隔性保护袋中的残留溶剂。方法使用DB-624毛细管色谱柱,载气为氮气,载气流速为1.5 mL·min^-1,程序升温,FID检测器,检测器温度为220℃。顶空进样:平衡温度为90℃,平衡时间为30 min。结果甲醇、乙醇、异丙醇、正丙醇、丁酮、乙酸乙酯、环己烷、丙二醇甲醚、乙酸丙酯、甲苯、乙酸丁酯的平均回收率为93.13%~100.94%,样品检测结果显示各残留溶剂的量均符合规定。结论本方法操作简便,重复性好,灵敏度高,测定溶剂种类多,能满足测定阻隔性保护袋中残留溶剂的要求。OBJECTIVE To develop a headspace gas chromatography method for the determination of residual organic solvents in barrier protective bag. METHODS The method was performed on a capillary chromatographic column of DB-624. The carrier gas was nitrogen with the flow rate set at 1. 5 mL·min^-1. The programmed temperature was applied and FID was used as detector at the temperature of 220 ℃. The equilibrium temperature was 90 ℃,which last for 30 min. RESULTS The average recoveries of methanol,ethanol,isopropanol,n-propanol,butanone,ethyl acetate,cyclohexane,propylene glycol methyl ether,propyl acetate,toluene,butyl acetate were between 93.13%-100.94%. The test results of the samples showed that the amount of residual solvent were in accordance with the requirement. CONCLUSION This method is simple with good repeatability and high sensitivity,which can meet the requirement of determining multiple residual solvents in the barrier protective bag.

关 键 词：顶空气相色谱法 阻隔性保护袋 残留溶剂 

分 类 号：R917[医药卫生—药物分析学]