Quantification of rosuvastatin in human plasma by automated solid-phase extraction using tandem mass spectrometric detection.
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 degrees 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.
Hull
C K
CK
Quintiles Scotland Limited, Research Avenue South, Heriot-Watt University Research Park, Riccarton, Edinburgh EH14 4AP, UK. caroline.hull@quintiles.com
Penman
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AD
Smith
C K
CK
Martin
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PD
D002853:Chromatography, Liquid / Q000379:methods*; D005464:Fluorobenzenes / Q000097:blood*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000097:blood*; D013058:Mass Spectrometry / Q000379:methods*; D011743:Pyrimidines; D015203:Reproducibility of Results; D000068718:Rosuvastatin Calcium; D012680:Sensitivity and Specificity; D013449:Sulfonamides
D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium