Determination of palonosetron in human plasma by liquid chromatography–electrospray ionization-mass spectrometry

Abstract

A high performance liquid chromatography–electrospray ionization-mass spectrometry (HPLC–ESI-MS) method for the determination of palonosetron (PALO) in human plasma using naloxone as the internal standard (IS) was established. After adjustment to a weakly basic pH with saturated sodium bicarbonate, plasma samples were extracted with ethyl acetate and separated on a Hanbon Lichrospher 5-C 18 column with a mobile phase of 40 mM ammonium acetate buffer solution containing 0.04% formic acid–methanol (46:54, v/v). PALO was determined with electrospray ionization-mass spectrometry (ESI-MS). HPLC–ESI-MS was performed in the selected-ion monitoring (SIM) mode using target ions at [M + H] + m/ z 297.2 for PALO and [M + H] + m/ z 328.2 for the IS. Calibration curve was linear over the range of 0.02124–10.62 ng/ml. The lower limit of quantification (LLOQ) was 0.02124 ng/ml. The intra- and inter-run variability values were all less than 10.4%. The method has been successfully applied to determine the plasma concentration of PALO in healthy Chinese volunteers.