制备型高效液相色谱法在药杂质研究中的应用.pdfVIP

Drug Evaluation Research 第 35 卷 第 3 期 2012 年 6 月 - 233 - 制备型高效液相色谱法在药物杂质研究中的应用 1 2 2 2 * 刘小琳 ，宋丽明 ，雷勇胜 ，蒋庆峰 1. 天津中医药大学，天津 300193 2. 天津药物研究院 分析测试中心，天津 300193 摘 要：制备型高效液相色谱法是一种使用高压、大流量液体输送系统在高分辨率、大内径、高载量分离柱上进行样品高纯 度分离的液相色谱制备方法。应用该方法分离的产品在纯度、回收率、分离效率等方面远远优于传统的制备方法，因此在药 物研究、生产领域得到广泛应用。介绍制备型高效液相色谱法的研究概况，特点，影响制备型高效液相色谱分离纯化的因素， 以及在药物杂质研究中的实际应用，并对制备型高效液相色谱技术存在的问题与发展方向进行总结。 关键词：制备型 HPLC ；方法开发；杂质研究；应用；综述 中图分类号：R917 文献标志码：A 文章编号：1674 - 6376 (2012) 03 - 0233 - 04 Application of preparative high performance liquid chromatography in the study on impurities of drugs 1 2 2 2 LIU Xiao-lin , SONG Li-ming , LEI Yong-sheng , JIANG Qing-feng 1. Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China 2. Center for Instrumentation Analysis, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China Abstract: Preparative high performance liquid chromatography (HPLC) is a way to use high-pressure, large flow of liquid delivery system for high-purity separation of the sample on high-resolution, large internal diameter, high capacity separation column. Application of the method for the separation of products in terms of purity, recovery, separation efficiency is far superior to the traditional method of preparation, and it is widely used in drug research and production fields. The efficient preparative HPLC steps, the preparative HPLC research and development direction, and the research on drug impurities in practical applications have been summarized. This article describes the research profile, characteristics of preparative HPLC, and factors that influence the process of separation and purification, steps to develop and establish the method, as well as the application of preparative HPLC