Sensitive and selective LC-MS-MS assay for the quantification of palonosetron in human plasma and its application to a pharmacokinetic study

摘要

A highly sensitive and selective liquid chromatography-tandem mass spectrometry method was developed for the determination of palonosetron in human plasma samples. Chromatographic conditions and mass spectral parameters were optimized in order to achieve a limit of quantification of approximately 0.03 ng mL(-1). Palonosetron and citalopram (internal standard) were extracted by liquid-liquid extraction under alkaline conditions using saturated sodium bicarbonate. Separation was achieved with a Hanbon Lichrospher C-18 column and detection was carried out by tandem mass spectrometry using positive electrospray ionization in selected reaction monitoring mode. The target ions of palonosetron and citalopram were to m/z 297.00 -> 297.00 and 325.00 -> 325.00 respectively. Calibration curves were linear over the range of approximately 0.03-10 ng mL(-1). Precision and accuracy of this method was acceptable. The method was successfully applied to a pharmacokinetic study with healthy Chinese volunteers after intravenous administration of a single dose of 0.125, 0.25 or 0.5 mg palonosetron hydrochloride.