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Simultaneous measurement of amiodarone and desethylamiodarone in human plasma and serum by stable isotope dilution liquid chromatography-tandem mass spectrometry assay.
J Pharm Biomed Anal. 2010 Jan 05; 51(1):210-6.JP

Abstract

A stable isotope dilution liquid chromatography-electrospray ionization tandem mass spectrometry (LC-MS/MS) assay to measure amiodarone, the most frequently used agent for maintaining sinus rhythm in patients with atrial fibrillation, and its major metabolite desethylamiodarone in human plasma and serum was developed. Measurement of amiodarone and desethylamiodarone was performed during a 4.0-min run-time using amiodarone-D(4) and desethylamiodarone-D(4) as internal standards. Calibration curves covering 12 calibrators measured in four replicates each for the analysis of both amiodarone and desethylamiodarone were linear and reproducible in the range of 0.01-40.0 mg/L (r>0.999). Limits of detection in plasma matrix were 2.7 microg/L for amiodarone and 1.9 microg/L for desethylamiodarone, and lower limits of quantification in plasma matrix were 7.5 microg/L for amiodarone and 2.5 microg/L for desethylamiodarone. Interassay imprecision and inaccuracy were <8% and <9% for both substances. Mean extraction yield was 99.6% (range 92.6-107.7%) for amiodarone and 90.2% (range 80.0-94.7%) for desethylamiodarone. Agreement was moderate for amiodarone (n=162) and desethylamiodarone (n=117), respectively, between the present method and a HPLC method with UV detection using a commercially available reagent set for the HPLC analysis of these drugs. The Passing-Bablok regression line was HPLC=0.98 (LC-MS/MS)+0.10 [mg/L]; r=0.94 for amiodarone and HPLC=1.05 (LC-MS/MS)+0.02 [mg/L]; r=0.90 for desethylamiodarone. This sensitive and interference-free LC-MS/MS assay permits rapid and accurate determination of amiodarone and desethylamiodarone in human plasma and other body fluids.

Authors+Show Affiliations

Institut für Laboratoriums- und Transfusionsmedizin, Herz- und Diabeteszentrum Nordrhein-Westfalen, Universitätsklinik der Ruhr-Universität Bochum, Bad Oeynhausen, Germany. jkuhn@hdz-nrw.deNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Validation Study

Language

eng

PubMed ID

19720490

Citation

Kuhn, Joachim, et al. "Simultaneous Measurement of Amiodarone and Desethylamiodarone in Human Plasma and Serum By Stable Isotope Dilution Liquid Chromatography-tandem Mass Spectrometry Assay." Journal of Pharmaceutical and Biomedical Analysis, vol. 51, no. 1, 2010, pp. 210-6.
Kuhn J, Götting C, Kleesiek K. Simultaneous measurement of amiodarone and desethylamiodarone in human plasma and serum by stable isotope dilution liquid chromatography-tandem mass spectrometry assay. J Pharm Biomed Anal. 2010;51(1):210-6.
Kuhn, J., Götting, C., & Kleesiek, K. (2010). Simultaneous measurement of amiodarone and desethylamiodarone in human plasma and serum by stable isotope dilution liquid chromatography-tandem mass spectrometry assay. Journal of Pharmaceutical and Biomedical Analysis, 51(1), 210-6. https://doi.org/10.1016/j.jpba.2009.08.004
Kuhn J, Götting C, Kleesiek K. Simultaneous Measurement of Amiodarone and Desethylamiodarone in Human Plasma and Serum By Stable Isotope Dilution Liquid Chromatography-tandem Mass Spectrometry Assay. J Pharm Biomed Anal. 2010 Jan 5;51(1):210-6. PubMed PMID: 19720490.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Simultaneous measurement of amiodarone and desethylamiodarone in human plasma and serum by stable isotope dilution liquid chromatography-tandem mass spectrometry assay. AU - Kuhn,Joachim, AU - Götting,Christian, AU - Kleesiek,Knut, Y1 - 2009/08/12/ PY - 2009/04/01/received PY - 2009/07/29/revised PY - 2009/08/03/accepted PY - 2009/9/2/entrez PY - 2009/9/2/pubmed PY - 2010/1/29/medline SP - 210 EP - 6 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 51 IS - 1 N2 - A stable isotope dilution liquid chromatography-electrospray ionization tandem mass spectrometry (LC-MS/MS) assay to measure amiodarone, the most frequently used agent for maintaining sinus rhythm in patients with atrial fibrillation, and its major metabolite desethylamiodarone in human plasma and serum was developed. Measurement of amiodarone and desethylamiodarone was performed during a 4.0-min run-time using amiodarone-D(4) and desethylamiodarone-D(4) as internal standards. Calibration curves covering 12 calibrators measured in four replicates each for the analysis of both amiodarone and desethylamiodarone were linear and reproducible in the range of 0.01-40.0 mg/L (r>0.999). Limits of detection in plasma matrix were 2.7 microg/L for amiodarone and 1.9 microg/L for desethylamiodarone, and lower limits of quantification in plasma matrix were 7.5 microg/L for amiodarone and 2.5 microg/L for desethylamiodarone. Interassay imprecision and inaccuracy were <8% and <9% for both substances. Mean extraction yield was 99.6% (range 92.6-107.7%) for amiodarone and 90.2% (range 80.0-94.7%) for desethylamiodarone. Agreement was moderate for amiodarone (n=162) and desethylamiodarone (n=117), respectively, between the present method and a HPLC method with UV detection using a commercially available reagent set for the HPLC analysis of these drugs. The Passing-Bablok regression line was HPLC=0.98 (LC-MS/MS)+0.10 [mg/L]; r=0.94 for amiodarone and HPLC=1.05 (LC-MS/MS)+0.02 [mg/L]; r=0.90 for desethylamiodarone. This sensitive and interference-free LC-MS/MS assay permits rapid and accurate determination of amiodarone and desethylamiodarone in human plasma and other body fluids. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/19720490/Simultaneous_measurement_of_amiodarone_and_desethylamiodarone_in_human_plasma_and_serum_by_stable_isotope_dilution_liquid_chromatography_tandem_mass_spectrometry_assay_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(09)00508-1 DB - PRIME DP - Unbound Medicine ER -