| HPLC法测定硫酸氢氯吡格雷片中氯吡格雷含量的不确定度评定 |
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| 引用本文： | 朱莉.HPLC法测定硫酸氢氯吡格雷片中氯吡格雷含量的不确定度评定[J].北方药学,2014(12):4-5. |
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| 作者姓名： | 朱莉 |
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| 作者单位： | 安徽省芜湖市食品药品检验所 芜湖 241000 |
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| 摘 要： | 目的：建立HPLC法测定硫酸氢氯吡格雷片中氯吡格雷含量不确定度的评定方法。方法：通过建立HPLC法测定含量的数学模型，分析影响不确定度的因素，并对各个不确定度分量进行评估。结果：硫酸氢氯吡格雷片中氯吡格雷含量测定的合成不确定度为0.5%；扩展不确定度为1.0%；测定结果为（101.0±1.0）%。结论：该法可用于HPLC法测定硫酸氢氯吡格雷片中氯吡格雷含量的不确定度评估。
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| 关 键 词： | 不确定度 HPLC法 硫酸氢氯吡格雷片 氯吡格雷 |
Evaluation of uncertainty for determination of clopidogrel in clopidogrel bisulfate tablets |
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| Zhu Li.Evaluation of uncertainty for determination of clopidogrel in clopidogrel bisulfate tablets[J].BEIFANG YAOXUE,2014(12):4-5. |
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| Authors: | Zhu Li |
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| Affiliation: | Zhu Li (Wuhu Institute for Food ＆ Drug Control,Wuhu 241000,China) |
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| Abstract: | Objective：To establish a method of uncertainty evaluation for the determination of clopidogrel in clopidogrel bisulfate tablets by HPLC.Methods：The calculation formula of uncertainty was deduced in the procedure of determining clopidogrel in tablets.Results：The combined uncertainty was 0.5%,the extended uncertainty was 1.0%,and the determined content was （101.0 ±1.0）%.Conclusion：This method is appropriate to be used in the uncertainty evaluation for the determination of clopidogrel in clopidogrel bisulfate tablets by HPLC. |
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| Keywords: | Uncertainty HPLC Clopidogrel bisulfate tablets Clopidogrel |
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