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| 顶空气相色谱法测定舒尼铂中5种有机溶剂残留量 |
| Residual Concentration Determination of Five Organic Solvents in Suniplatin by HS-GC |
| Received:January 20, 2020 |
| DOI： |
| 中文关键词: 舒尼铂 溶剂残留量 顶空气相色谱法(HS-GC) |
| 英文关键词: Suniplatin residual solvents HS-GC |
| 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 | | YANG Xiao-yan* | Yunnan Institute of Materia Medica, Yunnan Province Company Key Laboratory for TCM and Ethnic Drug of New Drug Creation, Kunming 650111, China | wangzhiqi110207@126.com | | SHEN Hong-ya | Yunnan Institute of Materia Medica, Yunnan Province Company Key Laboratory for TCM and Ethnic Drug of New Drug Creation, Kunming 650111, China | | | JIANG Jing | Kunming Institute of Precious Metals, Kunming 650106, China | | | GAO An-li | Kunming Institute of Precious Metals, Kunming 650106, China | | | YANG Zhi | Yunnan Institute of Materia Medica, Yunnan Province Company Key Laboratory for TCM and Ethnic Drug of New Drug Creation, Kunming 650111, China | | | WANG Jing-kun | Yunnan Institute of Materia Medica, Yunnan Province Company Key Laboratory for TCM and Ethnic Drug of New Drug Creation, Kunming 650111, China | | | XU Hong-gui | Yunnan Institute of Materia Medica, Yunnan Province Company Key Laboratory for TCM and Ethnic Drug of New Drug Creation, Kunming 650111, China | |
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| 中文摘要: |
| 建立了同时测定舒尼铂中乙醇、乙酸乙酯、四氢呋喃、环己烷及1,4-二氧六环共5种残留有机溶剂的顶空气相色谱分析方法。以Agilent DB-624毛细管色谱柱为分离柱，N,N-二甲基甲酰胺(DMF)为载体溶剂，氢火焰离子化检测器检测，外标法计算含量。在选定条件下，5种有机试剂分离度良好，在选定浓度范围内线性关系良好，相关系数(r)均不小于0.999；加标回收率为98.68%~ 101.05%，相对标准偏差(RSD)均不大于2.07%；检测限为0.32~2.64 μg/mL；定量限为0.81~6.59 μg/mL。测定结果满足舒尼铂中5种有机溶剂残留量限值检测要求。 |
| 英文摘要: |
| A HS-GC method was developed for the simultaneous determination of five residual organic solvents in Suniplatin, including ethanol, ethyl acetate, tetrahydrofuran, cyclohexane, and 1,4-dioxane. Using an Agilent DB-624 capillary column as the separation column, DMF as the carrier solvent and a hydrogen flame ionization detector for detection, and the results were calculated by the external standard method. Under the selected conditions, the separation resolution of the five organic reagents was satisfactory and the linear relationship was excellent in the range of the selected concentrations. The correlation coefficient (r) was not less than 0.999, and the average recovery rate was 98.68%~101.05%. The relative standard deviation (RSD) was less than 2.07%. The minimum detectable concentration of the five organic solvents was 0.32 to 2.64 μg/mL. The quantification limit was 0.81 to 6.59 μg/mL. The determination results meet the requirements of the residue limit of five organic solvents in Suniplatin. |
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