药用玻璃包装容器相容性试验中硅、硼迁移量测定的研究

目的:研究玻璃容器中硅、硼向药液里迁移的测定方法。方法:硅采用石墨炉原子吸收分光光度法测定,波长251.61 nm,狭缝1.8/1.35 mm,110℃干燥30 s,1450℃灰化30 s,2650℃原子化3 s,2680℃清洁5s;硼采用电感耦合等离子体质谱法测定,射频功率1.550 kW,载气流量0.99 L·min^-1,采样深度8 mm,采样锥孔径1.0 mm。结果:硅的检测限为1.2 ng·mL^-1,线性浓度范围0~85 ng·mL^-1,r=0.9956,平均回收率(n=9)为95.85%;硼的检测限为0.95 ng·mL^-1,线性范围2~400 ng·mL^-1,r=1.0000,平均回收率(n=9)为106.5%。不同生产厂家的低硼硅玻璃安瓿中硅的迁移量为4.9~12.2 μg·mL^-1,硼的迁移量为0.2~1.1 μg·mL^-1;不同规格中性硼硅玻璃输液瓶中硅的迁移量为2.2~5.3 μg·mL^-1,硼的迁移量为0.3 μg·mL^-1;不同规格钠钙玻璃输液瓶硅的迁移量为1.6~2.7 μg·mL^-1。结论:该方法灵敏快速,准确,重复性好,可用于药用玻璃包装容器相容性试验中硅、硼迁移量的测定。

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