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Simultaneous determination of mifepristone and monodemethyl-mifepristone in human plasma by liquid chromatography-tandem mass spectrometry method using levonorgestrel as an internal standard: application to a pharmacokinetic study.
Biomed Chromatogr. 2009 Jan; 23(1):71-80.BC

Abstract

A rapid and sensitive liquid chromatography/tandem mass spectrometry (LC-MS/MS) method was developed and validated to simultaneously determine mifepristone and monodemethyl-mifepristone in human plasma using levonorgestrel as the internal standard (IS). After solid-phase extraction of the plasma samples, mifepristone, monodemethyl-mifepristone and the IS were subjected to LC-MS/MS analysis using electro-spray ionization (ESI) in the multiple reaction monitoring (MRM) mode. Chromatographic separation was performed on an XTERRA MS C(18) column (150 x 2.1 mm i.d., 5 microm). The method had a chromatographic run time of 4.5 min and linear calibration curves over the concentration ranges of 5-2000 ng/mL for mifepristone and monodemethyl-mifepristone. The recoveries of the method were found to be 94.5-103.7% for mifepristone and 70.7-77.3% for monodemethyl-mifepristone. The method had a lower limit of quantification (LLOQ) of 5.0 ng/mL and a lower limit of detection (LOD) of 1.0 ng/mL for both mifepristone and monodemethyl-mifepristone. The intra- and inter-batch precision was less than 15% for all quality control samples at concentrations of 10, 100 and 1000 ng/mL. These results indicate that the method was efficient with a short run time (4.5 min) and acceptable accuracy, precision and sensitivity. The validated LC-MS/MS method was successfully used in a pharmacokinetic study in healthy female volunteers after oral administration of 25 mg mifepristone tablet.

Authors+Show Affiliations

Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, 74 Zhongshan Road II, Guangzhou 510080, People's Republic of China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

18816505

Citation

Tang, Cheng, et al. "Simultaneous Determination of Mifepristone and Monodemethyl-mifepristone in Human Plasma By Liquid Chromatography-tandem Mass Spectrometry Method Using Levonorgestrel as an Internal Standard: Application to a Pharmacokinetic Study." Biomedical Chromatography : BMC, vol. 23, no. 1, 2009, pp. 71-80.
Tang C, Bi HC, Zhong GP, et al. Simultaneous determination of mifepristone and monodemethyl-mifepristone in human plasma by liquid chromatography-tandem mass spectrometry method using levonorgestrel as an internal standard: application to a pharmacokinetic study. Biomed Chromatogr. 2009;23(1):71-80.
Tang, C., Bi, H. C., Zhong, G. P., Chen, X., Huang, Z. Y., & Huang, M. (2009). Simultaneous determination of mifepristone and monodemethyl-mifepristone in human plasma by liquid chromatography-tandem mass spectrometry method using levonorgestrel as an internal standard: application to a pharmacokinetic study. Biomedical Chromatography : BMC, 23(1), 71-80. https://doi.org/10.1002/bmc.1086
Tang C, et al. Simultaneous Determination of Mifepristone and Monodemethyl-mifepristone in Human Plasma By Liquid Chromatography-tandem Mass Spectrometry Method Using Levonorgestrel as an Internal Standard: Application to a Pharmacokinetic Study. Biomed Chromatogr. 2009;23(1):71-80. PubMed PMID: 18816505.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Simultaneous determination of mifepristone and monodemethyl-mifepristone in human plasma by liquid chromatography-tandem mass spectrometry method using levonorgestrel as an internal standard: application to a pharmacokinetic study. AU - Tang,Cheng, AU - Bi,Hui-Chang, AU - Zhong,Guo-Ping, AU - Chen,Xiao, AU - Huang,Zhi-Ying, AU - Huang,Min, PY - 2008/9/26/entrez PY - 2008/9/26/pubmed PY - 2009/2/24/medline SP - 71 EP - 80 JF - Biomedical chromatography : BMC JO - Biomed Chromatogr VL - 23 IS - 1 N2 - A rapid and sensitive liquid chromatography/tandem mass spectrometry (LC-MS/MS) method was developed and validated to simultaneously determine mifepristone and monodemethyl-mifepristone in human plasma using levonorgestrel as the internal standard (IS). After solid-phase extraction of the plasma samples, mifepristone, monodemethyl-mifepristone and the IS were subjected to LC-MS/MS analysis using electro-spray ionization (ESI) in the multiple reaction monitoring (MRM) mode. Chromatographic separation was performed on an XTERRA MS C(18) column (150 x 2.1 mm i.d., 5 microm). The method had a chromatographic run time of 4.5 min and linear calibration curves over the concentration ranges of 5-2000 ng/mL for mifepristone and monodemethyl-mifepristone. The recoveries of the method were found to be 94.5-103.7% for mifepristone and 70.7-77.3% for monodemethyl-mifepristone. The method had a lower limit of quantification (LLOQ) of 5.0 ng/mL and a lower limit of detection (LOD) of 1.0 ng/mL for both mifepristone and monodemethyl-mifepristone. The intra- and inter-batch precision was less than 15% for all quality control samples at concentrations of 10, 100 and 1000 ng/mL. These results indicate that the method was efficient with a short run time (4.5 min) and acceptable accuracy, precision and sensitivity. The validated LC-MS/MS method was successfully used in a pharmacokinetic study in healthy female volunteers after oral administration of 25 mg mifepristone tablet. SN - 1099-0801 UR - https://www.unboundmedicine.com/medline/citation/18816505/Simultaneous_determination_of_mifepristone_and_monodemethyl_mifepristone_in_human_plasma_by_liquid_chromatography_tandem_mass_spectrometry_method_using_levonorgestrel_as_an_internal_standard:_application_to_a_pharmacokinetic_study_ L2 - https://doi.org/10.1002/bmc.1086 DB - PRIME DP - Unbound Medicine ER -