Publication: Development and validation of a high-throughput zwitterionic hydrophilic interaction liquid chromatography solid-phase extraction-liquid chromatography-tandem mass spectrometry method for determination of the anti-influenza drug peramivir in plasma
Issued Date
2008-12-26
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ISSN
00219673
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2-s2.0-56949107313
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Mahidol University
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SCOPUS
Bibliographic Citation
Journal of Chromatography A. Vol.1215, No.1-2 (2008), 145-151
Suggested Citation
N. Lindegardh, W. Hanpithakpong, A. Phakdeeraj, P. Singhasivanon, J. Farrar, T. T. Hien, N. J. White, N. P.J. Day Development and validation of a high-throughput zwitterionic hydrophilic interaction liquid chromatography solid-phase extraction-liquid chromatography-tandem mass spectrometry method for determination of the anti-influenza drug peramivir in plasma. Journal of Chromatography A. Vol.1215, No.1-2 (2008), 145-151. doi:10.1016/j.chroma.2008.11.009 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/18793
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Title
Development and validation of a high-throughput zwitterionic hydrophilic interaction liquid chromatography solid-phase extraction-liquid chromatography-tandem mass spectrometry method for determination of the anti-influenza drug peramivir in plasma
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Abstract
An assay for the analysis for the quantification of the anti-influenza drug peramivir in human plasma using high-throughput zwitterionic (ZIC) hydrophilic interaction liquid chromatography (HILIC) solid-phase extraction (SPE) in a 96-wellplate format and liquid chromatography coupled to positive tandem mass spectroscopy has been developed and validated. The ZIC-HILIC SPE efficiently removed sources of interference present in the supernatant after protein precipitation of plasma proteins. The main advantage of the ZIC-HILIC SPE sample preparation step was that it allowed load and elution conditions to be optimised to extract only peramivir and minimize co-extraction of lipophilic phospholipids. The method was validated according to published US Food and Drugs Administration guidelines and showed excellent performance. The assay was validated over two calibration ranges (0.952-500 and 50-50,000 ng/mL) to support analysis of peramivir after intra-venous administration. The lower limit of quantification for peramivir in plasma was 1 ng/mL and the upper limit of quantification was 50,000 ng/mL. The within-day and between-day precisions expressed as RSD, were lower than 8% at all tested quality control concentrations and below 11% at the lower limit of quantification. Validation of over-curve samples ensured that it would be possible with dilution if samples went outside the calibration range. © 2008 Elsevier B.V. All rights reserved.