| HPLC 法测定硫酸氢氯吡格雷片有关物质的不确定度评定 |
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| 引用本文： | 张筱,杨丽蓉,彭帅. HPLC 法测定硫酸氢氯吡格雷片有关物质的不确定度评定[J]. 中国药品标准, 2018, 19(6): 459-464 |
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| 作者姓名： | 张筱 杨丽蓉 彭帅 |
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| 作者单位： | 潍坊市食品药品检验检测中心,潍坊市食品药品检验检测中心,山东得益乳业有限公司 |
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| 摘 要： | 目的：对高效液相色谱法(HPLC)测定硫酸氢氯吡格雷片有关物质的不确定度进行评估,找出影响不确定度因素。方法：建立数学模型,对有关物质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,最终得出测量结果的扩展不确定度。结论：分析产生不确定度的主要来源,为有效控制该有关物质测定方法的准确性提供可靠的理论依据。
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| 关 键 词： | 高效液相色谱法；硫酸氢氯吡格雷片；有关物质；不确定度分析 |
| 收稿时间： | 2018-05-14 |
| 修稿时间： | 2018-11-30 |
Uncertainty for determination of the related substances in clopidogrel hydrogen sulfate tablets by HPLC |
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| Affiliation: | Food and drug inspection and testing center of Weifang,Weifang Institute for Food and Drug Control and Shandong Deyi Dairy Co., Ltd |
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| Abstract: | Objective: To evaluate the uncertainty for determination of the related substances in clopidogrel hydrogen sulfate tablets by HPLC and to find the affecting factors of the uncertainty. Methods: The mathematical model was established, and the affecting factors of the uncertainty were analyzed and evaluated. Results: By calculating the uncertainty of each variable and synthesizing the uncertainty, the extended uncertainty for the determination result was obtained. Conclusion: Analyzing the main sources of uncertainty, which provides a reliable theory basis for the effective controlling of the determination method about the related substances in clopidogrel hydrogen sulfate tablets. |
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| Keywords: | HPLC Clopidogrel hydrogen sulfate tablets The related substances Uncertainty Analysis |
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