| 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 |
| HPLC 法测定硫酸氢氯吡格雷片有关物质的不确定度评定 |
| Uncertainty for determination of the related substances in clopidogrel hydrogen sulfate tablets by HPLC |
| 投稿时间：2018-05-14 修订日期：2018-11-30 |
| DOI： |
| 中文关键词: 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 |
| 英文关键词: HPLC Clopidogrel hydrogen sulfate tablets The related substances Uncertainty Analysis |
| 基金项目: |
|
| 摘要点击次数: 557 |
| 全文下载次数: 0 |
| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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. |
|
查看/发表评论 下载PDF阅读器 |
| 关闭 |