| 引用本文: | 谢莉,张亿,廉向金,陈红.ICP-MS同时测定氢化可的松注射液中21种元素杂质的迁移量[J].中国现代应用药学,2022,39(22):2959-2966. |
| XIE Li,ZHANG Yi,LIAN Xiangjin,CHEN Hong.Simultaneous Determination of Migration in Twenty-one Elemental Impurities from Hydrocortisone Injection by ICP-MS[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(22):2959-2966. |
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| 摘要: |
| 目的 建立同时测定氢化可的松注射液中21种元素杂质(Hg、As、Cd、Pb、Co、V、Ni、Li、Sb、Cu、Ba、Cr、Fe、Zn、Mn、Al、B、Ca、Mg、Si、Ti)含量的电感耦合等离子体质谱法(inductively coupled plasma mass spectrometry，ICP-MS)。方法 采用标准加入法，样品经稀释直接进样，以Ge、In、Bi元素为内标，采用ICP-MS测定67批样品和加速试验样品中的21种元素杂质的含量。结果 各元素在相应的浓度范围内均具有良好的线性关系(r≥0.999 8)，加样回收率为96.10%~101.94%，RSD均<4.34%(n=9)。随着时间的推移，Al元素发生了迁移，各元素的每日摄入量均低于相应的每日允许暴露量。结论 该方法简便快速，具有良好的灵敏度和准确度，可用于氢化可的松注射液中21种元素杂质迁移量的检测。 |
| 关键词: 电感耦合等离子体质谱|氢化可的松注射液|迁移量 |
| DOI：10.13748/j.cnki.issn1007-7693.2022.22.009 |
| 分类号:R971.101 |
| 基金项目: |
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| Simultaneous Determination of Migration in Twenty-one Elemental Impurities from Hydrocortisone Injection by ICP-MS |
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XIE Li, ZHANG Yi, LIAN Xiangjin, CHEN Hong
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Chengdu Institute for Drug Control, Chengdu 610045, China
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| Abstract: |
| OBJECTIVE To establish a method for the simultaneous determination of twenty-one elemental impurities(Hg, As, Cd, Pb, Co, V, Ni, Li, Sb, Cu, Ba, Cr, Fe, Zn, Mn, Al, B, Ca, Mg, Si, Ti)in hydrocortisone injection by inductively coupled plasma mass spectrometry(ICP-MS). METHODS Standard addition method was employed, and samples were determined after dilution. With Ge, In, Bi as the internal standard elements, the contents of twenty-one elemental impurities in 67 batches of hydrocortisone injection and that in accelerated experimental samples were determined by ICP-MS. RESULTS Each element had a good linear relationship within the corresponding concentration range(r≥0.999 8). The recoveries were in the range of 96.10%-101.94%, with these RSDs <4.34%(n=9). The content of Al increased over time, but the daily intake of each element was below the permitted daily exposure. CONCLUSION This method is convenient, rapid, has good sensitivity and accuracy, and can be used for the determination of twenty-one elemental impurities in hydrocortisone injection. |
| Key words: ICP-MS|hydrocortisone injection|migration |
