ICP-MS法同时测定氟[18F]化钠注射液中11种元素杂质含量

The Simultaneous Determinations of 11 Element Impurities in Sodium[18F]Fluoride Injection by ICP-MS

目的建立同时测定氟[18F]化钠注射液中11种金属元素杂质含量的方法。方法采用电感耦合等离子体质谱法(ICP-MS)测定。射频功率1500W,等离子气流速15.0L/min,辅助气流速1.0L/min,载气流速1.0L/min,采样深度0.75mm,采样锥孔径1.0mm,截取锥孔径0.4mm,雾化室温度2℃,蠕动泵速0.1r/s。结果砷、铅、镉、汞、钒、镍、钴、锂、铜、锑和铬的标准曲线线性关系良好,相关系数均大于0.99;定量限为0.005~0.53ng/mL,检测限为0.002~0.16ng/mL;精密度实验的相对标准偏差(RSD)均小于2.67%;重复性试验的RSD均小于15.0%;加样回收率在76.9%~114.2%之间,RSD值在0.33%~8.99%之间;耐用性试验的RSD均小于25%。结论该方法操作简便、准确,精密度、重复性、耐用性好,可用于氟[18F]化钠注射液11种金属元素杂质含量的同时测定。

Objective To establish a method for the simultaneous determinations of 11 element impurities in sodium[18F]fluoride injection.Methods Inductively coupled plasma mass spectrometry(ICP-MS)was used to determine the contents of various elements in sodium[18F]fluoride injection with emissive power of 1500 W.The relevant parameters were as following:the plasma flow rate of 15.0 L/min,auxiliary gas current flow of 1.0 L/min,carrier gas velocity of 1.0 L/min,sampling depth of 0.75 mm,sampling cone diameter of 1.0 mm,intercepting cone diameter of 0.4 mm,atomizing chamber temperature of 2℃,and peristaltic pump flow of 0.1rps.Results The standard curves of As,Pb,Cd,Hg,V,Ni,Co,Li,Cu,Sb and Cr had good linear relationships(r>0.99).The quantitation limit ranged as 0.005-0.53 ng/mL,and detection limits ranged as 0.002-0.16 ng/mL.RSD of precision test was lower than 2.67%,and RSD of repeatability test was lower than 15.0%.The recoveries were 76.9%-114.2%(RSD were 0.33%-8.99%)and RSD of durability tests were all lower than 25%.Conclusion The developed method is simple,accurate,precise,reproducible and durable,which can be used for simultaneous determinations of 11 element impurities in[18F]sodium fluoride.