Determination of palonosetron in human plasma by liquid chromatography-electrospray ionization-mass spectrometry.
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-C18 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.
Ding
Li
L
Department of Pharmaceutical Analysis, China Pharmaceutical University, 24 Tongjiaxiang, Nanjing 210009, China. dinglidl@hotmail.com
Chen
Yan
Y
Yang
Lin
L
Wen
Aidong
A
D000328:Adult; D000932:Antiemetics / Q000097:blood* / Q000493:pharmacokinetics; D019540:Area Under Curve; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D005260:Female; D006207:Half-Life; D006801:Humans; D007202:Indicators and Reagents; D007546:Isoquinolines / Q000097:blood* / Q000493:pharmacokinetics; D008297:Male; D000077924:Palonosetron; D011786:Quality Control; D011812:Quinuclidines / Q000097:blood* / Q000493:pharmacokinetics; D015203:Reproducibility of Results; D012996:Solutions; D021241:Spectrometry, Mass, Electrospray Ionization
D000932:Antiemetics; D007202:Indicators and Reagents; D007546:Isoquinolines; D011812:Quinuclidines; D012996:Solutions; D000077924:Palonosetron