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dc.contributor.authorShao, Changxing
dc.contributor.authorDowling, Thomas C.
dc.contributor.authorHaidar, Sam H.
dc.contributor.authorYu, L. X.
dc.contributor.authorPolli, James E.
dc.contributor.authorKane, Maureen A.
dc.date.accessioned2013-01-24T20:49:22Z
dc.date.available2013-01-24T20:49:22Z
dc.date.issued2012
dc.identifier.citationShao, C., Dowling, T. C., Haidar, S. H., Yu, L. X., Polli, J. E., & Kane, M. A., (2012). Quantification of Acyclovir in Human Plasma by Ultra-High-Performance Liquid Chromatography - Heated Electrospray Ionization - Tandem Mass Spectrometry for Bioequivalence Evaluation. Journal of Analytical & Bioanalytical Techniques, 3(4), DOI: 10.4172/2155-9872.1000139.en_US
dc.identifier.urihttp://hdl.handle.net/10713/2295
dc.descriptionAuthor affiliations: 1. Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland, USA 2. Clinical Pharmacology Unit, Department of Pharmacy Practice and Science, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA 3. Food and Drug Administration, Rockville, Maryland, USAen_US
dc.description.abstractPharmacokinetic studies are essential towards determining bioequivalence and establishing pharmacokinetic profiles for drug moieties requires accurate quantification. We report a rapid, sensitive, and robust method for the determination of acyclovir in human plasma and its validation towards evaluating the bioequivalence of drug formulations. After a simple liquid-liquid extraction from plasma, acyclovir is quantified using ultra-high-performance liquid chromatography - heated electrospray ionization - tandem mass spectrometry (UHPLC-HESI-MS/MS). The assay has a total analysis time is 5 min, a linear range of 1.0 - 2000 ng/mL, a lower limit of detection of 0.5 ng/ mL, and a lower limit of quantification of 1.0 ng/mL. Intra- and inter-day precision is no more than 10.3% and intraand inter-day accuracy was within 13% at various concentrations in human plasma. Validation according to FDA guidelines for bioanalysis indicates that the described UHPLC-HESI-MS/MS method provides rigorous quantification of acyclovir in human plasma and representative data demonstrates successful application towards the determination of pharmacokinetic profiles as part of an evaluation of drug formulation bioequivalence.en_US
dc.language.isoen_USen_US
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectultra high performance liquid chromatographyen_US
dc.subjectquantificationen_US
dc.subject.meshAcycloviren_US
dc.subject.meshTandem Mass Spectrometryen_US
dc.subject.meshPharmacokineticsen_US
dc.subject.meshPlasmaen_US
dc.titleQuantification of Acyclovir in Human Plasma by Ultra-High-Performance Liquid Chromatography - Heated Electrospray Ionization - Tandem Mass Spectrometry for Bioequivalence Evaluationen_US
dc.typeArticleen_US
dc.description.versionPeer Reviewed
dc.identifier.doi10.4172/2155-9872.1000139
dc.identifier.ispublishedNoen_US
refterms.dateFOA2019-02-19T17:29:31Z


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