RRML - New high-throughput liquid chromatographic tandem mass spectrometry assay for therapeutic drug monitoring of carvedilol in children with congestive heart failure

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Concept, Design & Programming
Dr. Adrian Man

Nr. 15(2)/2009

New high-throughput liquid chromatographic tandem mass spectrometry assay for therapeutic drug monitoring of carvedilol in children with congestive heart failure

Angela Butnariu, Daniela-Saveta Popa, Laurian Vlase, Mariana Andreica, Dana Muntean, Sorin Leucuţa

Abstract:

A new high-throughput liquid chromatography tandem mass spectrometry (LC-MS/MS) assay for the quantification of carvedilol in human plasma was developed and validated. The separation was performed on a Zorbax SB-C18 column under isocratic conditions using a 34:66 (v/v) mixture of acetonitrile and 0.2% (v/v) formic acid in water at 42 ºC with a flow rate of 0.3 mL/min. The detection of carvedilol was performed in multi-ple reaction monitoring (MRM) mode (m/z 222, 224, 283 from m/z 407). The human plasma samples (0.2 mL) were deproteinized with methanol, and aliquots of 15 μL from the supernatants obtained after centrifugation were directly injected into the chromatographic system. The method shows a good linearity (r > 0.9979), precision (CV < 12.9 %) and accuracy (bias < 7.8 %) over the range of 1.63-180.9 ng/mL plasma. The lower limit of quantification (LLOQ) was 1.63 ng/mL and the recovery was between 95-109.8 %. The method is not expensive, it needs a minimum time for plasma sample preparation and has a run-time of 2 min for instrument analysis (retention time of carvedilol was 1.75 min). The developed and validated high-throughput method is very simple, rapid and efficient, with wide applications in clinical therapeutic drug monitoring, pharmacokinetics and bioequivalence studies.

Keywords: carvedilol,LC-MS/MS,therapeutic drug monitoring

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Butnariu A, Popa DS, Vlase L, Andreica M, Muntean D, Leucuţa S. New high-throughput liquid chromatographic tandem mass spectrometry assay for therapeutic drug monitoring of carvedilol in children with congestive heart failure. Rev Romana Med Lab. 2009;15(2):7-15