摘要
建立了电感耦合等离子体质谱(ICP-MS)法测定富马酸丙酚替诺福韦(1)中铅(Pb)、钒(V)、砷(As)、汞(Hg)、镉(Cd)、钴(Co)、镍(Ni)、铬(Cr)8种元素杂质。样品经溶解后,加入内标溶液[含铋(Bi)、钇(Y)、铟(In)和钪(Sc)元素],稀释后直接进样。结果显示,8种元素杂质的线性关系良好,检测限为0.21~7.69μg/kg,定量限为0.71~25.60μg/kg;加样回收率(n=9)在93.41%~108.88%;重复性试验RSD(n=6)为0.64%~1.56%;溶液在室温2 h内稳定性良好。多批次样品中各元素杂质含量均远小于其限度值。该研究建立的方法专属性好、灵敏度高、准确度与精密度良好,可满足1中元素杂质的质量控制。
An inductively coupled plasma mass spectrometry(ICP-MS)method was established to determine 8 elemental impurities,namely Pb,V,As,Hg,Cd,Co,Ni,and Cr,in tenofovir alafenamide fumarate(1).The sample was dissolved and diluted with an internal standard solution(containing Bi,Y,In,and Sc elements).Then,the sample was directly injected into the ICP-MS system.The results showed that it was linear for the 8 elements in the corresponding concentration ranges.The detection limits were 0.21-7.69μg/kg,and the quantification limits were 0.71-25.60μg/kg.The sample recovery rates(n=9)were 93.41%-108.88%,the RSDs(n=6)of the repeatability test were 0.64%-1.56%.The solution had good stability within 2 hours at room temperature.The content of each element impurity in multiple batches of samples was far below its limit value.The established method has good specificity,high sensitivity,and good accuracy and precision,which can meet the quality control of element impurities in 1.
作者
李亚雷
李月华
韩飞
ICPLI Yalei;LI Yuehua;HAN Fei(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016)
出处
《中国医药工业杂志》
2025年第4期536-540,共5页
Chinese Journal of Pharmaceuticals
关键词
富马酸丙酚替诺福韦
乙型肝炎
元素杂质
电感耦合等离子体质谱
内标法
tenofovir alafenamide fumarate
viral hepatitis B
elemental impurity
inductively coupled plasma mass spectrometry
internal standard method
