Research Article
Quantification of Acyclovir in Human Plasma by Ultra-High-Performance Liquid Chromatography - Heated Electrospray Ionization - Tandem Mass Spectrometry for Bioequivalence Evaluation
Changxing Shao1, Thomas C Dowling2, Sam Haidar3, Lawrence X Yu3, James E Polli1, and Maureen A Kane1*
1Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland, USA
2Clinical Pharmacology Unit, Department of Pharmacy Practice and Science, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA
3Food and Drug Administration, Rockville, Maryland, USA
- *Corresponding Author:
- Maureen A Kane
Department of Pharmaceutical Sciences, University of Maryland
20 N. Pine St.; Pharmacy Hall North 723
Baltimore, MD21201,USA
Tel: 11-410-706-5097
Fax: 11-410-706-5017
E-mail: mkane@rx.umaryland.edu
Received date: June 27, 2012; Accepted date: July 31, 2012; Published date: August 06, 2012
Citation: Shao C, Dowling TC, Haidar S, Yu LX, Polli JE, et al. (2012) Quantification of Acyclovir in Human Plasma by Ultra-High-Performance Liquid Chromatography - Heated Electrospray Ionization - Tandem Mass Spectrometry for Bioequivalence Evaluation. J Anal Bioanal Tech 3:139. doi: 10.4172/2155-9872.1000139
Copyright: © 2012 Shao C, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
Pharmacokinetic 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.
