THE HPLC ASSAY OF ONDANSETRON HYDROCHLORIDE AND ITS IMPURITIES USING A NEW STATIONARY PHASE.
ANDREEA VARVARA, CRINA-MARIA MONCIU, CORINA ARAMĂ, C. POPESCU
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Abstract:

A high performance liquid chromatography method for separation and assay of ondansetron hydrochloride and some of its possible impurities in bulk and dosage forms was developed. Taking into account that ondansetron hydrochloride and its impurities have polarizable structures, the objective of this work was to identify a new suitable stationary phase for an optimal separation of these polar compounds. In such cases, the use of porous graphitic carbon (PCG), a stationary phase with good retention properties of very polar analytes was elected. PCG is different from classical stationary phases and has special ability to retain these analytes types and to separate closely related compounds, due to a combination of two mechanisms: adsorption and charge induced interactions of a polar analyte with the polarizable surface of graphite. We studied the behavior of ondansetron hydrochloride and its possible impurities in a chromatographic system using a Hypercarb column and mixtures of acetonitrile and polar solvents with acidic modifiers (trifluoroacetic acid) as mobile phase. The research resulted in a new method for separation and quantitative estimation of ondansetron hydrochloride and its impurities in bulk and dosage forms.

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