ICP-MS标准加入法测定药用玻璃容器中金属元素的浸出量

Determination of Leaching Amount of Metal Elements in Pharmaceutical Glass Containers by ICP-MS and Standard Addition Method

采用标准加入ICP-MS法测定药用玻璃容器在3种不同提取条件下可浸出金属元素含量,仪器工作参数:标准测定模式,同心雾化器,射频功率为1.50 kW,等离子体氩气流速为15 L·min^-1,载气流速为1.0 L·min^-1,采样深度为5.0 mm,蠕动泵速0.1 r·s^-1,雾化室温度为2℃。该方法可同时测定17种金属元素,各元素在一定的浓度范围内呈良好的线性关系,线性相关系数为0.999~1.000;加样回收率为90%~110%。经方法学验证,可用于药用玻璃容器中金属元素浸出量的测定。

ICP-MS was used for the determination of extractable components in pharmaceutical glass containers under 3 different extraction conditions.The parameters of instrument were as follows:general measurement mode,concentric nebulizer,radio-frequency(RF)power of 1.50 kW,plasma argon gas flow rate of 15 L·min^-1,carrier gas flow of 1.0 L·min^-1,sampling depth of 5.0 mm,peristaltic pump speed of 0.1 r·s^-1,atomizing chamber temperature of 2℃,quantitative analysis model and internal standard added online.The method can be used for the simultaneous determination of 17 elements,and each element had a good linear relationship within a certain concentration range.The linear correlation was 0.999~1.000,and the recoveries were 90%~110%.It is specific,sensitive,accurate and rapid,which can be used for the determination of leaching amount of metal elements in pharmaceutical glass containers.