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| 微波消解-ICP-MS法测定舒尼铂原料药中银的残留量 |
| Determination of Residual Silver Content in Shuniplatin API by Microwave Digestion-ICP-MS |
| Received:April 21, 2020 |
| DOI： |
| 中文关键词: 分析化学 抗癌药 舒尼铂 银残留量 微波消解 电感耦合等离子体质谱(ICP-MS) |
| 英文关键词: analytical chemistry anti-cancer drug Shuniplatin silver residue microwave digestion ICP-MS |
| 基金项目:国家重大新药创制专项(2009ZX09103-109)；云南省新药开发专项(2014BC010) |
| Author Name | Affiliation | E-mail | | ZHANG Xiao-nan | Drug of New Drug Creation, Yunnan Baiyao Group Innovation and R& D Center, Kunming 650111, China | xiaonan1242@126.com | | PU Bing-qing | Drug of New Drug Creation, Yunnan Baiyao Group Innovation and R& D Center, Kunming 650111, China | | | CHEN Xue-jiang | Drug of New Drug Creation, Yunnan Baiyao Group Innovation and R& D Center, Kunming 650111, China | | | XU Hong-gui | Drug of New Drug Creation, Yunnan Baiyao Group Innovation and R& D Center, Kunming 650111, China | | | WANG Jing-kun | Drug of New Drug Creation, Yunnan Baiyao Group Innovation and R& D Center, Kunming 650111, China | | | LIU Wei-ping | Kunming Institute of Precious Metals, Kunming 650106, China | | | YANG Xiao-yan | Drug of New Drug Creation, Yunnan Baiyao Group Innovation and R& D Center, Kunming 650111, China | wangzhiqi110207@126.com |
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| 中文摘要: |
| 采用微波消解法进行样品前处理，以电感耦合等离子体质谱法(ICP-MS)测定了舒尼铂原料药中的银残留量。结果表明，银质量浓度在0.1~150 μg/L的范围内，与银信号强度和内标铟信号强度的比值呈良好的线性关系，重复性试验的RSD为2.32%，加标回收率为95.89%~104.81%，检出限为0.0109 μg/g，定量限为0.0365 μg/g；3批样品测定结果分别为2.42、1.54和1.96 μg/g。方法可满足舒尼铂原料药中银残留量测定的要求。 |
| 英文摘要: |
| The content of residual silver in Shuniplatin active pharmaceutical ingredients(Shuniplatin API) was determined by ICP-MS after sample digested by closed-vessel microwave system. The results indicated that the ratio of the signal intensity of silver to the internal indium standard showed a good linear relationship in the concentration ranges of 0.1~150 μg/L. The relative standard deviation was 2.32%, and the recovery of silver was 95.89%~104.81%. The limit of detection was 0.0109 μg/g, while the limit of quantitation was 0.0365 μg/g. The determined silver content in three batches of samples was 2.42, 1.54 and 1.96 μg/g, respectively. It suggests that the method can meet the requirements of silver residue determination in Shuniplatin API. |
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