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超高效液相色谱法在药物分析中的应用优势。

Advantages of application of UPLC in pharmaceutical analysis.

作者信息

Nováková Lucie, Matysová Ludmila, Solich Petr

机构信息

Department of Analytical Chemistry, Faculty of Pharmacy, Charles University, Heyrovského 1203, Hradec Králové, Czech Republic.

出版信息

Talanta. 2006 Jan 15;68(3):908-18. doi: 10.1016/j.talanta.2005.06.035. Epub 2005 Jul 27.

DOI:10.1016/j.talanta.2005.06.035
PMID:18970409
Abstract

Ultra Performance Liquid Chromatography (UPLC) is a relatively new technique giving new possibilities in liquid chromatography, especially concerning decrease of time and solvent consumption. UPLC chromatographic system is designed in a special way to withstand high system back-pressures. Special analytical columns UPLC Acquity UPLC BEH C(18) packed with 1.7 microm particles are used in connection with this system. The quality control analyses of four pharmaceutical formulations were transferred from HPLC to UPLC system. The results are compared for Triamcinolon cream containing trimacinolone acetonide, methylparaben, propylparaben and triamcinolone as degradation product, for Hydrocortison cream (hydrocortisone acetate, methylparaben, propylparaben and hydrocortisone degradation product), for Indomethacin gel (indomethacin and its degradation products 4-chlorobenzoic acid and 5-methoxy-2-methylindoleacetic acid) and for Estrogel gel (estradiol, methylparaben, propylparaben and estrone as degradation product). The UPLC system allows shortening analysis time up to nine times comparing to the conventional system using 5 microm particle packed analytical columns. In comparison with 3 microm particle packed analytical columns analysis should be shortened about three times. The negative effect of particle decrease is back-pressure increase about nine times (versus 5 microm) or three times (versus 3 microm), respectively. The separation on UPLC is performed under very high pressures (up to 100MPa is possible in UPLC system), but it has no negative influence on analytical column or other components of chromatographic system. Separation efficiency remains maintained or is even improved. Differences and SST parameters, advantages and disadvantages of UPLC are discussed.

摘要

超高效液相色谱法(UPLC)是一种相对较新的技术,为液相色谱法带来了新的可能性,特别是在缩短分析时间和减少溶剂消耗方面。UPLC色谱系统采用特殊设计,以承受高系统背压。与此系统配套使用的是填充有1.7微米颗粒的特殊分析柱UPLC Acquity UPLC BEH C18。四种药物制剂的质量控制分析从高效液相色谱法(HPLC)转移到了UPLC系统。对含有曲安奈德、对羟基苯甲酸甲酯、对羟基苯甲酸丙酯和作为降解产物的曲安奈德的曲安奈德乳膏、对含有醋酸氢化可的松、对羟基苯甲酸甲酯、对羟基苯甲酸丙酯和氢化可的松降解产物的氢化可的松乳膏、对含有吲哚美辛及其降解产物4-氯苯甲酸和5-甲氧基-2-甲基吲哚乙酸的吲哚美辛凝胶以及对含有雌二醇、对羟基苯甲酸甲酯、对羟基苯甲酸丙酯和作为降解产物的雌酮的雌二醇凝胶的结果进行了比较。与使用填充有5微米颗粒的分析柱的传统系统相比,UPLC系统可将分析时间缩短多达九倍。与填充有3微米颗粒的分析柱相比,分析时间应缩短约三倍。颗粒减小的负面影响是背压分别增加约九倍(相对于5微米)或三倍(相对于3微米)。UPLC上的分离在非常高的压力下进行(UPLC系统中高达100MPa是可能的),但对分析柱或色谱系统的其他组件没有负面影响。分离效率得以保持甚至提高。讨论了UPLC的差异和SST参数、优缺点。

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