Determination of tropisetron in human plasma by high performance liquid chromatographic method with UV detection and its application to a bioequivalence study.

A simple and sensitive high performance liquid chromatography method with UV detection was described for the determination of tropisetron in human plasma. The prepared sample solution was injected onto BDS-C(8) reversed column using a mixture of ammonium acetate (100 mM, PH adjusted to 4.3 with glacial acetic acid) and acetonitrile (80:20, v/v) as mobile phase. The wavelength of UV detector was set at 285 nm. No interference from any endogenous substances was observed during the elution of tropisetron and internal standard (ondansetron hydrochloride). The lower limit of quantification was evaluated to be 1 ng/mL. The method was used in a randomized crossover bioequivalence study of two different tropisetron preparations in 20 healthy volunteers.