| 采用HPLC法测定左氧氟沙星杂质A含量的不确定度分析 |
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| 引用本文： | 钟丽红,刘颖,王维剑. 采用HPLC法测定左氧氟沙星杂质A含量的不确定度分析[J]. 药物分析杂志, 2011, 0(11) |
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| 作者姓名： | 钟丽红 刘颖 王维剑 |
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| 作者单位： | 山东大学齐鲁医院;山东省交通医院急诊科;山东省药品检验所; |
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| 基金项目： | 国家科技重大专项课题-重大新药创制(2009ZX09313-023) |
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| 摘 要： | 目的:建立HPLC法标定左氧氟沙星杂质A对照品含量的不确定度评定方法。方法:建立数学模型,对含量测定过程中各影响因素进行分析评估。结果:通过计算各变量的不确定度,合成不确定度,最终得出测定结果的扩展不确定度。结论:该评定方法适用于HPLC法标定左氧氟沙星杂质A对照品含量的不确定度评定。
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| 关 键 词： | HPLC 左氧氟沙星 对照品 杂质 标定 不确定度 |
HPLC evaluation of uncertainty for the determination of cefuroxime reference substance A |
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| ZHONG Li-hong,LIU Ying,WANG Wei-jing. HPLC evaluation of uncertainty for the determination of cefuroxime reference substance A[J]. Chinese Journal of Pharmaceutical Analysis, 2011, 0(11) |
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| Authors: | ZHONG Li-hong LIU Ying WANG Wei-jing |
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| Affiliation: | ZHONG Li-hong1,LIU Ying2,WANG Wei-jing3(1.Qilu Hospital of Shandong University,Jinan 250012,China,2.Office of Pharmacy of Shandong Jiaotong Hospital,Jinan 250031,3.Shandong Provincial Institute for Drug Control,Jinan 250101,China) |
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| Abstract: | Objective:To establish a method of uncertainty evaluation for the determination of levofloxacin impurity A reference substance by HPLC.Methods: The uncertainty was evaluated by a established mathematical model and the analysis of various factors affecting sample detection.Results: Each componet of uncertainty was calculated and then the combined uncertainty was finally obtained by synthesizing the uncertainties of various component variables.Conclusions:This method is appropriate to be used in the uncertain... |
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| Keywords: | HPLC levofloxacin reference substance impurity standardization uncertainty |
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