超级微波消解-ICP-MS法同时检测交联羧甲纤维素钠中12种元素杂质

Simultaneous Determination of 12 Elemental Impurities in Croscarmellose Sodium by Ultra Microwave-assisted Digestion and Inductively Coupled Plasma Mass Spectrometry

建立超级微波消解和ICP-MS的方法并进行方法学验证。用所建方法对2个厂家的4批次交联羧甲纤维素钠中的1类、2A类、3类Li、Sb、Cu以及其他元素Fe和Zn共12种元素进行检测,按注射给药控制阈值方法进行风险评估。结果所建方法线性、检测限、定量限、准确度、精密度均符合法规要求,实测数据显示Co、V、Ni、Sb、Cu、Fe、Zn均有检出,但含量均未超注射给药途径的控制阈值,可知交联羧甲纤维素钠用于注射给药时元素杂质残留风险较低。

A method for microwave-assisted digestion combined with ICP-MS was established,and methodological validation was conducted.Using the established method,12 elements were detected,including Class 1,2A,and 3 elements Li,Sb,Cu,as well as other elements like Fe and Zn,in 4 batches of croscarmellose sodium from two manufacturers.Risk assessment according to the control threshold method for injectable drugs was performed.The results showed that the established method met regulatory requirements in terms of linearity,detection limit,quantification limit,accuracy and precision.The actual test data indicated that Co,V,Ni,Sb,Cu,Fe and Zn were detected,but the levels did not exceed the control threshold for the injectable route of administration.The risk of elemental impurity residued in croscarmellose sodium when used in injectable drugs was low.