title: Potential employment of non-silica-based stationary phases in pharmaceutical analysis.
abstract: 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.
authors.affiliation: Charles University in Prague, Faculty of Pharmacy in Hradec Králové, Heyrovského 1203, 500 05 Hradec Králové, Czech Republic.
authors.forename: Václav
authors.initials: V
authors.lastname: Zizkovský
authors.forename: Radim
authors.initials: R
authors.lastname: Kucera
authors.forename: Jirí
authors.initials: J
authors.lastname: Klimes
mesh_terms: D000097:Acetonitriles / Q000737:chemistry; D002021:Buffers; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004340:Drug Contamination / Q000517:prevention & control; D006863:Hydrogen-Ion Concentration; D015394:Molecular Structure; D017294:Ondansetron / Q000032:analysis* / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry; D010710:Phosphates / Q000737:chemistry; D012015:Reference Standards; D058831:Serotonin 5-HT3 Receptor Antagonists; D012822:Silicon Dioxide / Q000737:chemistry*; D012996:Solutions / Q000737:chemistry; D013696:Temperature; D013997:Time Factors; D014025:Titanium / Q000737:chemistry*; D015040:Zirconium / Q000737:chemistry*
chemical_list: D000097:Acetonitriles; D002021:Buffers; D004364:Pharmaceutical Preparations; D010710:Phosphates; D058831:Serotonin 5-HT3 Receptor Antagonists; D012996:Solutions; C024788:ammonium phosphate; C009495:titanium dioxide; D017294:Ondansetron; D012822:Silicon Dioxide; D015040:Zirconium; D014025:Titanium; C032159:acetonitrile