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Determination of levonorgestrel in human plasma by liquid chromatography-tandem mass spectrometry method: application to a bioequivalence study of two formulations in healthy volunteers.
Biomed Chromatogr. 2008 May; 22(5):519-26.BC

Abstract

A rapid and sensitive liquid chromatography-tandem mass spectrometry (LC/MS/MS) method to determine levonorgestrel in human plasma was developed and fully validated. After hexane-ethyl acetate (70:30, v/v) induced extraction from the plasma samples, levonorgestrel was subjected to LC/MS/MS analysis using electro-spray ionization. The MS system was operated in the selected reaction monitoring mode. Chromatographic separation was performed on a Hypersil BDS C18 column (i.d. 2.1x50 mm, particle size 3 microm). The method had a chromatographic running time of 2.0 min and linear calibration curves over the concentration ranges of 0.25-90 ng/mL for levonorgestrel. The lower limit of quantification of the method was 0.25 ng/mL for levonorgestrel. The intra- and inter-batch precision was 3.7-10.2 and 5.1-12.9%, respectively, for all quality control samples at concentrations of 0.5, 6.0 and 45.0 ng/mL. These results indicate that the method was efficient with a simple preparation procedure and a very short running time (2.0 min) for levonorgestrel compared with those methods reported in the literature and had high selectivity, acceptable accuracy, precision and sensitivity. The validated LC/MS/MS method was successfully used for a bioequivalence study of two tablet formulations of levonorgestrel in healthy volunteers.

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Authors+Show Affiliations

Zhao LZ
School of Pharmaceutical Sciences, Sun Yat-sen University, 74 Zhongshan Road II, and Department of Pharmacy the First Affiliated Hospital, Guangzhou 510080, People's Republic of China.
Zhong GP
No affiliation info available
Bi HC
No affiliation info available
Ding L
No affiliation info available
Deng Y
No affiliation info available
Guan S
No affiliation info available
Chen X
No affiliation info available
Huang ZY
No affiliation info available
Huang M
No affiliation info available

MeSH

AdultChromatography, LiquidContraceptive Agents, FemaleFemaleHumansLevonorgestrelReproducibility of ResultsSpectrometry, Mass, Electrospray IonizationTandem Mass SpectrometryTherapeutic Equivalency

Pub Type(s)

Journal Article

Language

eng

PubMed ID

18254150

Citation

Zhao, Li-Zi, et al. "Determination of Levonorgestrel in Human Plasma By Liquid Chromatography-tandem Mass Spectrometry Method: Application to a Bioequivalence Study of Two Formulations in Healthy Volunteers." Biomedical Chromatography : BMC, vol. 22, no. 5, 2008, pp. 519-26.
Zhao LZ, Zhong GP, Bi HC, et al. Determination of levonorgestrel in human plasma by liquid chromatography-tandem mass spectrometry method: application to a bioequivalence study of two formulations in healthy volunteers. Biomed Chromatogr. 2008;22(5):519-26.
Zhao, L. Z., Zhong, G. P., Bi, H. C., Ding, L., Deng, Y., Guan, S., Chen, X., Huang, Z. Y., & Huang, M. (2008). Determination of levonorgestrel in human plasma by liquid chromatography-tandem mass spectrometry method: application to a bioequivalence study of two formulations in healthy volunteers. Biomedical Chromatography : BMC, 22(5), 519-26. https://doi.org/10.1002/bmc.963
Zhao LZ, et al. Determination of Levonorgestrel in Human Plasma By Liquid Chromatography-tandem Mass Spectrometry Method: Application to a Bioequivalence Study of Two Formulations in Healthy Volunteers. Biomed Chromatogr. 2008;22(5):519-26. PubMed PMID: 18254150.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Determination of levonorgestrel in human plasma by liquid chromatography-tandem mass spectrometry method: application to a bioequivalence study of two formulations in healthy volunteers. AU - Zhao,Li-Zi, AU - Zhong,Guo-Ping, AU - Bi,Hui-Chang, AU - Ding,Liang, AU - Deng,Ying, AU - Guan,Su, AU - Chen,Xiao, AU - Huang,Zhi-ying, AU - Huang,Min, PY - 2008/2/7/pubmed PY - 2008/7/3/medline PY - 2008/2/7/entrez SP - 519 EP - 26 JF - Biomedical chromatography : BMC JO - Biomed Chromatogr VL - 22 IS - 5 N2 - A rapid and sensitive liquid chromatography-tandem mass spectrometry (LC/MS/MS) method to determine levonorgestrel in human plasma was developed and fully validated. After hexane-ethyl acetate (70:30, v/v) induced extraction from the plasma samples, levonorgestrel was subjected to LC/MS/MS analysis using electro-spray ionization. The MS system was operated in the selected reaction monitoring mode. Chromatographic separation was performed on a Hypersil BDS C18 column (i.d. 2.1x50 mm, particle size 3 microm). The method had a chromatographic running time of 2.0 min and linear calibration curves over the concentration ranges of 0.25-90 ng/mL for levonorgestrel. The lower limit of quantification of the method was 0.25 ng/mL for levonorgestrel. The intra- and inter-batch precision was 3.7-10.2 and 5.1-12.9%, respectively, for all quality control samples at concentrations of 0.5, 6.0 and 45.0 ng/mL. These results indicate that the method was efficient with a simple preparation procedure and a very short running time (2.0 min) for levonorgestrel compared with those methods reported in the literature and had high selectivity, acceptable accuracy, precision and sensitivity. The validated LC/MS/MS method was successfully used for a bioequivalence study of two tablet formulations of levonorgestrel in healthy volunteers. SN - 0269-3879 UR - https://www.unboundmedicine.com/medline/citation/18254150/Determination_of_levonorgestrel_in_human_plasma_by_liquid_chromatography_tandem_mass_spectrometry_method:_application_to_a_bioequivalence_study_of_two_formulations_in_healthy_volunteers_ L2 - https://doi.org/10.1002/bmc.963 DB - PRIME DP - Unbound Medicine ER -
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