| 赵冯,张杞柳,陈辉,等.电感耦合等离子体质谱法测定盐酸溴己新葡萄糖注射液中 29种元素杂质含量[J].安徽医药,2024,28(1):36-40. |
| 电感耦合等离子体质谱法测定盐酸溴己新葡萄糖注射液中 29种元素杂质含量 |
| Content determination of 29 element impurities by inductively coupled plasma-mass spectrometry in bromhexine hydrochloride and glucose injection |
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| DOI：10.3969/j.issn.1009-6469.2024.01.008 |
| 中文关键词: 药物污染 盐酸溴己新葡萄糖注射液 电感耦合等离子体质谱法 国际药典委员会 Q3D元素杂质指导原则 元素杂质 基质匹配 |
| 英文关键词: Drug contamination Bromhexine hydrochloride and glucose injection Inductively coupled plasma-mass spectrosco- py ICH Q3D Elemental impurity Matrix matching |
| 基金项目:江苏省市场监督管理局科技计划项目( KJ21125019) |
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| 中文摘要: |
| 目的建立利用电感耦合等离子体质谱法( ICP-MS)同时测定盐酸溴己新葡萄糖注射液中 29种元素杂质含量的分析方法。方法自 2022年 9—10月，采用 ICP-MS法。样品直接稀释后分析，通过在线加入内标元素来校正测量结果。内标液添加异丙醇进行基质匹配以减少仪器信号漂移干扰和样品基体效应。射频功率 1 550 W；雾化气流量 1.05 L/min；辅助气流量0.90L/min；KED模式；碰撞气流量 4.5 mL/min；全定量法采集。结果 29个元素在各自的检测浓度范围内线性关系良好( r>0.9987)。检测限为 0.000 057 3~0.285 μg/L，平均回收率为 91.0%~108.4%(n=3)，重复性为 1.3%~7.2%(n=6)。结论该方法快速、准确、操作简便，可用于盐酸溴己新葡萄糖注射液中元素杂质的质量控制。 |
| 英文摘要: |
| Objective To develop a method for simultaneous content determination of 29 elemental impurities in bromhexine hydro-chloride and glucose injection by inductively coupled plasma-mass spectroscopy (ICP-MS). Methods From September to October 2022, ICP-MS method was adopted. Samples were analyzed after direct dilution, measurement results were corrected by adding internalstandard elements online. The internal standard solution was supplemented with 2-propanol for matrix matching to reduce the signaldrift and the interference of matrix effect. RF power was set at 1 550 W; the nebulizer gas flow was set at 1.05 L/min; auxilliary gas flowwas set at 0.90 L/min; KED mode; collision gas flow was set at 4.5 mL/min. The data were collected by quantitative method.Results The 29 elements showed good linearity in the specified concentration range with the correlation coefficients (r) being all above 0.998 7. Detection limits were 0.000 057 3-0.285 μg/L. The average recoveries were 91.0%-108.4% (n=3). The repeatability was 1.3%-7.2% (n= 6).Conclusion The method is rapid, accurate and simple, and applicable for the elemental impurity control of bromhexine hydrochlo-ride and glucose injection. |
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