Potential employment of non-silica-based stationary phases in pharmaceutical analysis

摘要

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_O2-based columns (e.g. Zr-PBD, Zr-PS, Zr-C18) and Ti O_2-based column were used. The effect of an organic modifier (type and ratio), a buffer (type, p H 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 m M, p H 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.