Zhilong Gong, Kiresha Chandler, Stephen Webster, Remy Kerley, Susan Buist, Melanie McCort-Tipton
Department of Bioanalytical Chemistry, Covance Inc., 8211 SciCor Dr., Indianapolis, IN 46214, USA. zhilong.gong@covance.com
Talanta 2012 Mar 15We report for the first time an ultra performance liquid chromatographic method with tandem mass spectrometric detection (UPLC/MS/MS) for the determination of norethindrone alone in human plasma over the concentration range of 50.0-25000 pg mL(-1) using a sample volume of 0.250 mL. Norethindrone and its internal standard (ISTD), norethindrone-(13)C(2), were extracted from human plasma by supported liquid extraction (SLE). After evaporation of the organic solvent, samples were reconstituted and analyzed on an UPLC/MS/MS system. The UPLC system used a Waters BEH C18 (100 mm × 2.1mm, 1.7 μm) column with mobile phase A of 0.05% formic acid in water:acetonitrile (65:35, v/v) and mobile phase B of 0.05% formic acid in methanol:acetonitrile (50:50, v/v). The flow rate was 0.500 mL min(-1). The method was fully validated. The inter-run accuracy and precision at the lower limit of quantitation (LLOQ), low, mid and high quality control (QC) concentration levels were 99.2-108.4% with a <8.1% CV (coefficient of variation), respectively. The validated method has been successfully applied to analysis of thousands of pharmacokinetic samples. Copyright © 2012 Elsevier B.V. All rights reserved.
Zhilong Gong, Kiresha Chandler, Stephen Webster, Remy Kerley, Susan Buist, Melanie McCort-Tipton. Simple and rapid determination of norethindrone in human plasma by supported liquid extraction and ultra performance liquid chromatography with tandem mass spectrometry. Talanta. 2012 Mar 15;91:77-82
PMID: 22365683
View Full Text