Development and validation of a sensitive method for simultaneous determination of rosuvastatin and N-desmethyl rosuvastatin in human plasma using liquid chromatography/negative electrospray ionization/tandem mass spectrometry
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AbstractA sensitive and specific liquid chromatography tandem mass spectrometric method was developed and validated for the simultaneous determination of rosuvastatin (ROS) and N-desmethyl rosuvastatin (NOR-ROS) in human plasma using deuterium-labeled internal standards. The plasma samples were prepared using liquid-liquid extraction with diethyl ether. Chromatographic separation was accomplished on an Xterra MS C-18 column. The mobile phase consisted of a gradient mixture of 15 mu mol/L ammonium acetate in water and in methanol, maintained at a flow rate of 0.4mL/min. Mass spectrometric detection was carried out in negative electrospray ionization mode and monitored by quantification and qualification transitions for each analyte. Using 300 L plasma samples, the lower limits of quantification of ROS and NOR-ROS were 0.05 and 0.02 mu g/L respectively. The linearity of ROS and NOR-ROS ranged from 0.05 to 42 and 0.02 to 14 mu g/L respectively. The relative standard deviations of ROS and NOR-ROS were <13 and 9%, respectively, while the deviations from expected values were within -4.7-9.8 and -5.2-4.6%, respectively. The present method offered high sensitivity and was successfully applied to a 24h pharmacokinetic study of ROS and NOR-ROS in healthy subjects receiving a single dose of 10mg ROS. Copyright (c) 2013 John Wiley & Sons, Ltd.
All Author(s) ListLee HK, Ho CS, Hu M, Tomlinson B, Wong CK
Journal nameBiomedical Chromatography
Detailed descriptionEpub 2013 May 30\n\nTo ORKTS: Published
Volume Number27
Issue Number11
PublisherWiley: 12 months
Pages1369 - 1374
LanguagesEnglish-United Kingdom
KeywordsHMG-CoA reductase inhibitor; LC; MS; N-desmethyl rosuvastatin; pharmacokinetics; rosuvastatin
Web of Science Subject CategoriesBiochemical Research Methods; BIOCHEMICAL RESEARCH METHODS; Biochemistry & Molecular Biology; BIOCHEMISTRY & MOLECULAR BIOLOGY; Chemistry; Chemistry, Analytical; CHEMISTRY, ANALYTICAL; Pharmacology & Pharmacy; PHARMACOLOGY & PHARMACY

Last updated on 2020-20-10 at 01:22