Quantification of rosuvastatin in human plasma by automated solid-phase extraction using tandem mass spectrometric detection

被引：91

作者：

Hull, Caroline K. ^{[1
]}

Penman, A.D. ^{[1
]}

Smith, C.K. ^{[1
]}

Martin, P.D. ^{[1
]}

机构：

[1] Quintiles Scotland Limited, Heriot-Watt University Research Park, Riccarton, Edinburgh EH14 4AP, United Kingdom

来源：

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences | 2002年 / 772卷 / 02期

关键词：

Bioassay - Enzyme inhibition - Freezing - High performance liquid chromatography - Mass spectrometry - Pharmacokinetics;

D O I：

10.1016/S1570-0232(02)00088-0

中图分类号：

学科分类号：

摘要：

An assay employing automated solid-phase extraction (SPE) followed by high-performance liquid chromatography with positive ion TurboIonspray tandem mass spectrometry (LC-MS-MS) was developed and validated for the quantification of rosuvastatin (Crestor™) in human plasma. Rosuvastatin is a hydroxy-methyl glutaryl coenzyme A reductase inhibitor currently under development by AstraZeneca. The standard curve range in human plasma was 0.1-30 ng/ml with a lower limit of quantification (LLOQ) verified at 0.1 ng/ml. Inaccuracy was less than 8% and imprecision less than ±15% at all concentration levels. There was no interference from endogenous substances. The analyte was stable in human plasma following three freeze/thaw cycles and for up to 6 months following storage at both -20 and -70°C. The assay was successfully applied to the analysis of rosuvastatin in human plasma samples derived from clinical trials, allowing the pharmacokinetics of the compound to be determined. © 2002 Elsevier Science B.V. All rights reserved.

引用

页码：219 / 228