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High-sensitivity simultaneous liquid chromatography-tandem mass spectrometry assay of ethinyl estradiol and levonorgestrel in human plasma

摘要A sensitive and simultaneous liquid chromatography-tandem mass spectrometry method was developed and validated for quantification of ethinyl estradiol and levonorgestrel. The analytes were extracted with methyl-tert-butyl ether: n-hexane (50:50, v/v) solvent mixture, followed by dansyl derivatization. The chromatographic separation was performed on a Kinetex C18 (50 mm × 4.6 mm, 2.6μm) column with a mobile phase of 0.1% (v/v) formic acid in water and acetonitrile in gradient composition. The mass transitions were monitored in electrospray positive ionization mode. The assay exhibited a linear range of 0.100-20.0 ng/mL for levonorgestrel and 4.00-500 pg/mL for ethinyl estradiol in human plasma. A run time of 9.0 min for each sample made it possible to analyze a throughput of more than 100 samples per day. The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic and bioequivalence studies.

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作者单位 Bioanalytical Research, Veeda Clinical Research, Ahmedabad 380059, India;Department of Pharmaceutical Chemistry, K. B. Institute of Pharmaceutical Education and Research, Kadi Sarva Vishawavidyalaya, Gandhinagar 382023, India [1] Bioanalytical Research, Veeda Clinical Research, Ahmedabad 380059, India [2] Department of Pharmaceutical Chemistry, K. B. Institute of Pharmaceutical Education and Research, Kadi Sarva Vishawavidyalaya, Gandhinagar 382023, India [3]
栏目名称 Original Article
DOI 10.1016/j.jpha.2015.02.002
发布时间 2015-11-13
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药物分析学报(英文)

药物分析学报(英文)

2015年5卷5期

316-326页

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