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    ICP-MS测定无载体三氯化镥177Lu溶液中的元素杂质

    Determination of Elemental Impurities in Carrier-free Lutetium Chloride 177Lu Solution by ICP-MS

      摘要
    • 摘要:
      目的  建立电感耦合等离子体质谱法(inductively coupled plasma-mass spectrometry，ICP-MS)测定国产无载体三氯化镥177Lu溶液中元素杂质的方法。
      方法 以Sc、Y、In、Bi为内标，采用ICP-MS方法测定，射频功率为1550 w，载气流量0.8 L·min−1，碰撞气体流速5.03 mL·min−1，雾化室温度2.7 ℃，采样深度5 mm。对所建立的方法进行方法学验证。
      结果 各元素在线性范围内线性关系良好(r均>0.9990)，低、中、高3个浓度的加样回收率(n=9)均在80%~118%。测定3批国产无载体三氯化镥177Lu溶液样品，结果3批样品均未检出国际人用药品注册技术协调会 Q3D元素指导原则规定的1类元素杂质，仅2A类元素Ni和2B类元素Ir微量检出。
      结论 该方法灵敏度、精密度、准确度良好，适用于无载体三氯化镥177Lu溶液元素杂质的质量控制。

       

      Abstract:
      OBJECTIVE  To establish an inductively coupled plasma-mass spectrometry(ICP-MS) method for determining elemental impurities in domestically produced carrier-free lutetium chloride 177Lu solution.
      METHODS  With Sc, Y, In, and Bi used as internal standards, an ICP-MS method was developed and established with the following conditions: RF power of 1550 W, carrier gas flow rate of 0.8 L·min−1, collision gas flow rate of 5.03 mL·min−1, nebulization chamber temperature of 2.7 °C, sampling depth of 5 mm. The method was validated for key analytical parameters.
      RESULTS  Each elements exhibited good linearity within the specified ranges(r>0.9990), the recovery rates at low, medium and high concentrations(n=9) were in 80%−118%. Three batches of carrier-free lutetium chloride 177Lu solution samples were tested, the test results indicated that Class 1 elemental impurities specified in the ICH Q3D guidelines were not detected, trace amounts of Class 2A element Ni and Class 2B element Ir were detected.
      CONCLUSION  The developed method demonstrates high sensitivity, good precision with good accuracy, making it suitable for quality control of elemental impurities in carrier-free lutetium chloride 177Lu solution.

       

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