Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
7615922 | Journal of Chromatography B | 2016 | 8 Pages |
Abstract
A rapid and sensitive LC-MS/MS method was developed, optimized and validated for quantification of sofosbuvir (SF) and ledipasvir (LD) in human plasma using eplerenone as an internal standard (IS). Analytes and IS were extracted from plasma by simple liquid-liquid extraction technique using methyl tertiary butyl ether. The prepared samples were chromatographed on Acquity UPLC BEH C18 column. Separation was done using a mobile phase formed of 0.1% formic acid and acetonitrile (50:50, v/v) in an isocratic mode at a flow rate of 0.4Â ml/min. The Xevo TQD LC-MS/MS was operated under the multiple-reaction monitoring mode using electrospray ionization. A full validation of the method was performed according to the FDA guidelines. Linearity was found to be in the range of 0.25-3500Â ng/ml for SF and 5-2000Â ng/ml for LD. The intra-day and inter-day precision and accuracy results were within the acceptable limits. A short run time of 2Â min allows analysis of more than 400 plasma samples per day. The developed method was successfully applied to both fasting and fed bioequivalence studies in healthy human volunteers.
Related Topics
Physical Sciences and Engineering
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Authors
Mamdouh R. Rezk, Ehab R. Bendas, Emad B. Basalious, Iman A. Karim,