What is it about?
A novel and sensitive LC-MS/MS method was developed and validated for determination of sofosbuvir in human plasma. The Xevo TQD LC-MS/MS was operated under the multiple-reaction monitoring mode using electrospray ionization. Extraction with tert-butyl methyl ether was used in sample preparation. The prepared samples were chromatographed on Acquity UPLC BEH C18 (50 x 2.1 mm, 1.7 μm) column by pumping 0.1% formic acid and acetonitrile in an isocratic mode at a flow rate of 0.35 ml/min. A very low quantification limit of sofosbuvir allowed the applicability of the developed method for determination of sofosbuvir in a bioequivalence study in human volunteers.
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Why is it important?
A very low quantification limit of sofosbuvir allowed the applicability of the developed method for determination of sofosbuvir in a bioequivalence study in human volunteers.
Perspectives
As per WHO guidelines, there is a need for a sensitive method capable of estimating sofosbuvir, not its metabolite, in quantification limit of 0.5 ng/ml or lower. A very short run time of one minute made it possible to analyze more than 500 human plasma samples per day. A very low quantification limit of sofosbuvir allowed the applicability of the developed method for determination of sofosbuvir in a bioequivalence study in human volunteers.
Professor Mamdouh Reda Rezk
Faculty of Pharmacy
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This page is a summary of: Novel and sensitive UPLC-MS/MS method for quantification of sofosbuvir in human plasma: application to a bioequivalence study, Biomedical Chromatography, February 2016, Wiley,
DOI: 10.1002/bmc.3690.
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