| 王丽.有关物质中误判杂质峰及形成机制的研究[J].中国药事,2019,33(11):1254-1258 |
| 有关物质中误判杂质峰及形成机制的研究 |
| Study on Misjudged Impurity Peaks and the Formation Mechanism in Related Substances |
| 投稿时间：2019-05-17 |
| DOI：10.16153/j.1002-7777.2019.11.007 |
| 中文关键词: 有关物质 杂质峰 高效液相色谱法 |
| 英文关键词: related substances impurity peak HPLC |
| 基金项目:无锡市科技发展基金（编号WX18IVJN714） |
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| 中文摘要: |
| 目的：分析高效液相色谱法检查有关物质时容易被误认为是杂质的峰，并进一步研究其形成机制。方法：结合日常检验工作和相关文献，对易被误认为是杂质峰进行研究总结。结果：易被误认为是杂质峰的包括溶剂峰、有机酸盐峰、无机酸盐峰和辅料峰，对这些峰的形成原因进行分析。结论：分析工作者在药物的有关物质高效液相色谱法的方法开发和检查中，应对检验过程中出现的杂质峰予以重视，以免出现误判。 |
| 英文摘要: |
| Objective:To analyze the peaks which are easily mistaken for impurity in related substances by high performance liquid chromatography (HPLC) and study their formation mechanisms. Methods:The peaks which are easily mistaken for impurity were summarized in combination with daily inspection work and related literature. Results:The peaks which are easily mistaken for impurity included peaks of solvent, peaks of organic acid salts, peaks of inorganic acid salts and peaks of ingredients. The possible reasons for the misjudged impurity peaks were analyzed. Conclusion:Analytical workers should pay attention to the impurity peaks appearing in the test process while developing and inspecting the related substances of drugs by using HPLC so as to avoid misjudgment. |
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