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Determination of palonosetron in human plasma by ultra performance liquid chromatography-tandem mass spectrometry and its application to a pharmacokinetic study.
J Pharm Biomed Anal. 2012 Jan 05; 57:13-8.JP

Abstract

A rapid, sensitive and selective ultra performance liquid chromatography-tandem mass spectrometric (UPLC-MS/MS) method was developed for the determination of palonosetron (PALO) in human plasma. Verapamil was used as the internal standard (I.S.). Sample pretreatment involved liquid-liquid extraction with diethyl ether under alkaline condition. Chromatographic separation was carried out on an ACQUITY UPLC™ HSS T(3) column with mobile phase consisting of methanol-water containing 0.1% formic acid (80:20, v/v) at a flow-rate of 0.20mL/min. The detection was performed on a triple quadrupole tandem mass spectrometer by multiple reaction monitoring (MRM) mode via electrospray ionization (ESI) source. The ion transitions of PALO and I.S. were m/z 297.3→109.8 and m/z 455.1→164.9, respectively. Each plasma sample was chromatographed within 1.2min. The linear calibration curves were obtained in the concentration range of 0.0190-3.80ng/mL (r(2)≥0.99) with a lower limit of quantification (LLOQ) of 0.0190ng/mL. The intra- and inter-day precision (relative standard deviation, R.S.D.) values were all less than 11% and accuracy (relative error, R.E.) was from 4.3% to 6.1% at all quality control (QC) levels. The method has been successfully applied to determine the plasma concentration of PALO in healthy Chinese volunteers after intravenous administration of a single dose of 0.125mg palonosetron hydrochloride.

Authors+Show Affiliations

Department of Analytical Chemistry, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenyang 110016, PR China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Validation Study

Language

eng

PubMed ID

21937184

Citation

Yang, Shuyan, et al. "Determination of Palonosetron in Human Plasma By Ultra Performance Liquid Chromatography-tandem Mass Spectrometry and Its Application to a Pharmacokinetic Study." Journal of Pharmaceutical and Biomedical Analysis, vol. 57, 2012, pp. 13-8.
Yang S, Qin F, Wang D, et al. Determination of palonosetron in human plasma by ultra performance liquid chromatography-tandem mass spectrometry and its application to a pharmacokinetic study. J Pharm Biomed Anal. 2012;57:13-8.
Yang, S., Qin, F., Wang, D., Li, N., Li, F., & Xiong, Z. (2012). Determination of palonosetron in human plasma by ultra performance liquid chromatography-tandem mass spectrometry and its application to a pharmacokinetic study. Journal of Pharmaceutical and Biomedical Analysis, 57, 13-8. https://doi.org/10.1016/j.jpba.2011.08.038
Yang S, et al. Determination of Palonosetron in Human Plasma By Ultra Performance Liquid Chromatography-tandem Mass Spectrometry and Its Application to a Pharmacokinetic Study. J Pharm Biomed Anal. 2012 Jan 5;57:13-8. PubMed PMID: 21937184.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Determination of palonosetron in human plasma by ultra performance liquid chromatography-tandem mass spectrometry and its application to a pharmacokinetic study. AU - Yang,Shuyan, AU - Qin,Feng, AU - Wang,Dan, AU - Li,Ning, AU - Li,Famei, AU - Xiong,Zhili, Y1 - 2011/09/01/ PY - 2011/1/19/received PY - 2011/8/24/revised PY - 2011/8/26/accepted PY - 2011/9/23/entrez PY - 2011/9/23/pubmed PY - 2012/1/31/medline SP - 13 EP - 8 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 57 N2 - A rapid, sensitive and selective ultra performance liquid chromatography-tandem mass spectrometric (UPLC-MS/MS) method was developed for the determination of palonosetron (PALO) in human plasma. Verapamil was used as the internal standard (I.S.). Sample pretreatment involved liquid-liquid extraction with diethyl ether under alkaline condition. Chromatographic separation was carried out on an ACQUITY UPLC™ HSS T(3) column with mobile phase consisting of methanol-water containing 0.1% formic acid (80:20, v/v) at a flow-rate of 0.20mL/min. The detection was performed on a triple quadrupole tandem mass spectrometer by multiple reaction monitoring (MRM) mode via electrospray ionization (ESI) source. The ion transitions of PALO and I.S. were m/z 297.3→109.8 and m/z 455.1→164.9, respectively. Each plasma sample was chromatographed within 1.2min. The linear calibration curves were obtained in the concentration range of 0.0190-3.80ng/mL (r(2)≥0.99) with a lower limit of quantification (LLOQ) of 0.0190ng/mL. The intra- and inter-day precision (relative standard deviation, R.S.D.) values were all less than 11% and accuracy (relative error, R.E.) was from 4.3% to 6.1% at all quality control (QC) levels. The method has been successfully applied to determine the plasma concentration of PALO in healthy Chinese volunteers after intravenous administration of a single dose of 0.125mg palonosetron hydrochloride. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/21937184/Determination_of_palonosetron_in_human_plasma_by_ultra_performance_liquid_chromatography_tandem_mass_spectrometry_and_its_application_to_a_pharmacokinetic_study_ DB - PRIME DP - Unbound Medicine ER -