ICP-MS法测定注射用单磷酸阿糖腺苷中15种元素杂质的含量

Determination of 15 Elemental Impurities in Vidarabine Monophosphate for Injection by ICP-MS

目的建立测定注射用单磷酸阿糖腺苷中15种杂质元素含量的测定方法。方法选取^(45)Sc、^(72)Ge、^(115)In、^(209)Bi这4种同位素作为内标,使用电感耦合等离子体-质谱法(ICP-MS法)进行测定。RF功率为1600 W,采样深度为10 mm,雾化器流速为0.77 L·min^(-1),稀释气体流速为0.14 L·min^(-1),蠕动泵为6 r·min^(-1)。结果各元素线性关系良好,相关系数(r)为0.9993~1.0000;方法检出限为0.0064~12.0531 ng·mL^(-1);回收率在90.0%~113.1%之间,相对标准偏差(RSD)均小于8%(n=9)。结论该方法准确,便捷,灵敏,适用于注射用单磷酸阿糖腺苷中杂质元素含量的测定。

OBJECTIVE To establish a method for determining the content of 15 elemental impurities in vidarabine monophosphate for injection.METHODS The four isotopes of ^(45)Sc,^(72)Ge,^(115)In and ^(209)Bi were selected as internal standards and measured by inductively coupled plasma-mass spectrometry(ICP-MS).The RF power was 1600 W,the sampling depth was 10 mm,the atomizer flow rate was 0.77 L·min^(-1),the dilution gas flow rate was 0.14 L·min^(-1),the peristaltic pump was 6 r·min^(-1).RESULTS The linear relationship of each element was good,the correlation coefficient(r)was 0.9993-1.0000.The detection limit of the method was 0.0064-12.0531 ng·mL^(-1).The recovery rate was between 90.0%-113.1%,and the relative standard deviation(RSD)was less than 8%(n=9).CONCLUSION The method is accurate,convenient and sensitive,and is suitable for the determination of impurity elements in vidarabine monophosphate for injection.