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非手性和手性超临界流体色谱在药物分析与纯化中的应用及实践

Use and practice of achiral and chiral supercritical fluid chromatography in pharmaceutical analysis and purification.

作者信息

Lemasson Elise, Bertin Sophie, West Caroline

机构信息

Institut de Chimie Organique et Analytique (ICOA), Univ Orleans, CNRS, Orléans cedex, France.

Institut de Recherches Servier, Suresnes, France.

出版信息

J Sep Sci. 2016 Jan;39(1):212-33. doi: 10.1002/jssc.201501062.

Abstract

The interest of pharmaceutical companies for complementary high-performance chromatographic tools to assess a product's purity or enhance this purity is on the rise. The high-throughput capability and economic benefits of supercritical fluid chromatography, but also the "green" aspect of CO2 as the principal solvent, render supercritical fluid chromatography very attractive for a wide range of pharmaceutical applications. The recent reintroduction of new robust instruments dedicated to supercritical fluid chromatography and the progress in stationary phase technology have also greatly benefited supercritical fluid chromatography. Additionally, it was shown several times that supercritical fluid chromatography could be orthogonal to reversed-phase high-performance liquid chromatography and could efficiently compete with it. Supercritical fluid chromatography is an adequate tool for small molecules of pharmaceutical interest: synthetic intermediates, active pharmaceutical ingredients, impurities, or degradation products. In this review, we first discuss about general chromatographic conditions for supercritical fluid chromatography analysis to better suit compounds of pharmaceutical interest. We also discuss about the use of achiral and chiral supercritical fluid chromatography for analytical purposes and the recent applications in these areas. The use of preparative supercritical fluid chromatography by pharmaceutical companies is also covered.

摘要

制药公司对用于评估产品纯度或提高纯度的补充性高性能色谱工具的兴趣正在上升。超临界流体色谱的高通量能力和经济效益,以及二氧化碳作为主要溶剂的“绿色”特性,使得超临界流体色谱在广泛的制药应用中极具吸引力。最近重新推出的专门用于超临界流体色谱的新型稳健仪器以及固定相技术的进步也极大地促进了超临界流体色谱的发展。此外,多次表明超临界流体色谱可以与反相高效液相色谱正交,并能与之有效竞争。超临界流体色谱是分析具有药学意义的小分子的合适工具:合成中间体、活性药物成分、杂质或降解产物。在本综述中,我们首先讨论超临界流体色谱分析的一般色谱条件,以更好地适用于具有药学意义的化合物。我们还讨论了非手性和手性超临界流体色谱在分析目的方面的应用以及这些领域的最新应用。制药公司对制备型超临界流体色谱的使用也在本文中有所涉及。

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