High-sensitivity simultaneous liquid chromatography-tandem mass spectrometry assay of ethinyl estradiol and levonorgestrel in human plasma
10.1016/j.jpha.2015.02.002
- Author:
Abhishek GANDHI
;
Swati GUTTIKAR
;
Priti TRIVEDI
- Publication Type:Journal Article
- Keywords:
Ethinyl estradiol;
Levonorgestrel;
LC-MS/MS;
Human plasma;
Derivatization
- From:
Journal of Pharmaceutical Analysis
2015;5(5):316-326
- CountryChina
- Language:Chinese
-
Abstract:
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.
