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

Autor: Priti Trivedi, Swati Guttikar, Abhishek Gandhi
Jazyk: angličtina
Rok vydání: 2015
Předmět:
Zdroj: Journal of Pharmaceutical Analysis, Vol 5, Iss 5, Pp 316-326 (2015)
Journal of Pharmaceutical Analysis
ISSN: 2095-1779
Popis: A sensitive and simultaneous liquid chromatographyâtandem 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 mmÃ4.6 mm, 2.6 µm) 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 0.100â20.0 ng/mL for levonorgestrel and 4.00â500 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. Keywords: Ethinyl estradiol, Levonorgestrel, LCâMS/MS, Human plasma, Derivatization
Databáze: OpenAIRE