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| 药物中有关物质的色谱分析研究近况 | |
| 引用本文： | 金祥飞,沈卫阳,党柱,宫旭,柯梦云,王欢欢. 药物中有关物质的色谱分析研究近况[J]. 药学进展, 2009, 33(12): 542-548. DOI: 10.3969/j.issn.1001-5094.2009.12.003 |
| 作者姓名： | 金祥飞 沈卫阳 党柱 宫旭 柯梦云 王欢欢 |
| 作者单位： | 中国药科大学分析化学教研室,质量与安全预警教育部重点实验室,江苏,南京210009 |
| 基金项目： | 中国药科大学大学生创新性实验计划 |
| 摘 要： | 综述近年来药物中有关物质检查的色谱分析技术及其应用，比较了各种方法的优缺点，并简要介绍了对药物中有关物质进行检查、结构分析的一般流程。药物中的有关物质与药物的质量密切相关，对有关物质的检测和控制也显得愈发重要。 |
| 关 键 词： | 有关物质 色谱法 药物分析 |
Recent Progress in Studies on Chromatographic Method for Analysis of the Related Impurities in Drugs |
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| JIN Xiang-fei,SHEN Wei-yang,DANG Zhu,GONG Xu,KE Meng-yun,WANG Huan-huan. Recent Progress in Studies on Chromatographic Method for Analysis of the Related Impurities in Drugs[J]. Progress in Pharmaceutical Sciences, 2009, 33(12): 542-548. DOI: 10.3969/j.issn.1001-5094.2009.12.003 | |
| Authors: | JIN Xiang-fei SHEN Wei-yang DANG Zhu GONG Xu KE Meng-yun WANG Huan-huan |
| Affiliation: | (Department of Analytical Chemistry, China Pharmaceutical University, Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education, Nanjing 210009, China) |
| Abstract: | The recent researches on determination and analysis of the related impurities in drugs by chromatographic methods were reviewed, including the comparison of their merits and disadvantages. The general procedure for structure analysis of the related impurities in drugs were also briefly introduced. The impurities are closely related to the drug quality, so the determination and control of the related impurities have become more and more important in drug research and development. |
| Keywords: | related impurity chromatographic method drug analysis |
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