气相色谱法测定聚乳酸类医疗器械产品中甲苯残留量  

Determination of Residual Toluene in Poly(Lactic Acid)(PLA) by GC

作　　者：王利霞 林红赛 刘曦 崔永平 岳卫华 WANG Li-xia;LIN Hong-sai;LIU Xi;CUI Yong-ping;YUE Wei-hua(YUE Wei-hua Beijing Institute of Medical Device Testing,Beijing 101111)

机构地区：[1]北京市医疗器械检验所,北京101111

出　　处：《中国医疗器械信息》2017年第6期4-6,共3页China Medical Device Information

摘　　要：目的:建立气相色谱方法测定聚乳酸中甲苯残留量的方法。方法:使用Agilent 7890气相色谱仪进行检测,色谱柱为HP-5(30m×0.320mm×0.25μm)非极性毛细管柱,升温程序:40?C保持4min,以30?C/min的速率升至240?C,保持4min。进样口温度:150?C,检测器:氢火焰离子化检测器(FID),检测器温度:280?C。采用外标法进行定量分析。结果:甲苯的线性范围为0.4695μg/mL^46.95.μg/mL(r=0.9999),检出限为0.04695μg/mL,平均加样回收率为99.93%,相对标准偏差为1.3%(n=9)。结论:该方法简便、快速、准确,可用于聚乳酸类医疗器械产品中甲苯的残留量测定。Objective:To establish a method for determination of residual toluene in poly(lactic acid)(PLA)by GC with FID detection.Method:GC analysis of residualtoluene in poly(lactic acid)(PLA)by a Agilent7890GC system equipped with FID detection.Column:HP-5(30m×0.320mm×0.25μm)nonpolar capillarycolumn.Temperature program:40℃for4min,and30?C/min rate to240℃,hold4min.inlet temperature:150℃,FID detection temperature:280℃,and thefinal residual toluene was quantified by external standard method.Result:The linear range of toluene was0.4695μg/mL^46.95μg/mL(r=0.9999).The limitdetection was0.04695μg/mL and the average recovery ratio was99.33%with a RSD of1.3%(n=9).Conclusion:The method is simple,rapid and accurate forthe content determination of toluene in poly(lactic acid)(PLA).

关 键 词：聚乳酸 甲苯 气相色谱法 

分 类 号：R318.08[医药卫生—生物医学工程]