Zizkovský Václav, Kucera Radim, Klimes Jirí
Charles University in Prague, Faculty of Pharmacy in Hradec Králové, Heyrovského 1203, 500 05 Hradec Králové, Czech Republic.
J Pharm Biomed Anal. 2007 Sep 3;44(5):1048-55. doi: 10.1016/j.jpba.2007.04.027. Epub 2007 Apr 25.
The absolute majority of the HPLC applications use silica-based columns for the separation of active substance and its impurities. However, stationary phases based on metal oxides appear as an interesting alternative. The aim of our study was to investigate the potential utilization of metal oxide-based stationary phases in analytical evaluation of ondansetron and its five pharmacopoeial impurities. In our study commercially available ZrO(2)-based columns (e.g. Zr-PBD, Zr-PS, Zr-C18) and TiO(2)-based column were used. The effect of an organic modifier (type and ratio), a buffer (type, pH and concentration) and the influence of temperature was investigated. The separation of ondansetron and its five pharmacopoeial impurities was successfully accomplished on a Zirchrom-PBD column using a mobile phase consisting of acetonitrile-ammonium phosphate (25 mM, pH 7.0) (18:82, v/v). Detection was performed at 216 nm and the analysis was completed within 7.5 min. The paper proves metal oxide-based stationary phases as an alternative to classical silica-based stationary phases in pharmaceutical analysis.
绝大多数高效液相色谱（HPLC）应用使用硅胶基色谱柱来分离活性物质及其杂质。然而，基于金属氧化物的固定相似乎是一种有趣的替代选择。我们研究的目的是调查基于金属氧化物的固定相在昂丹司琼及其五种药典杂质分析评估中的潜在应用。在我们的研究中，使用了市售的基于ZrO(2)的色谱柱（如Zr-PBD、Zr-PS、Zr-C18）和基于TiO(2)的色谱柱。研究了有机改性剂（类型和比例）、缓冲液（类型、pH值和浓度）的影响以及温度的影响。使用由乙腈-磷酸铵（25 mM，pH 7.0）（18:82，v/v）组成的流动相，在Zirchrom-PBD色谱柱上成功实现了昂丹司琼及其五种药典杂质的分离。检测在216 nm波长下进行，分析在7.5分钟内完成。本文证明了基于金属氧化物的固定相可作为药物分析中传统硅胶基固定相的替代品。
