Quantification of Acyclovir in Human Plasma by Ultra-High-Performance Liquid Chromatography - Heated Electrospray Ionization - Tandem Mass Spectrometry for Bioequivalence Evaluation
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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.
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, USA
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.
Keywordultra high performance liquid chromatography
Tandem Mass Spectrometry
Identifier to cite or link to this itemhttp://hdl.handle.net/10713/2295
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