Development and validation of bioanalytical method for the determination of Valcyclovir HCl in human plasma by liquid chromatoghraphy

Abstract

Valacyclovir hydrochloride (2-[(2-Amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxyl]ethyl ester-lvaline monohydrochloride), is an antiviral prescription medicine approved by the U.S. Food and Drug
Administration (FDA) to prevent genital herpes outbreaks in adults infected with HIV.A simple
method is described for the quantitation of Valcyclovir HCl in plasma by liquid chromatography.
Chromatographic separation was achieved on a reversed phase Hypersil ODS C18 (150mm * 4.6mm,
5.0 μm) column, using isocratic elution (acetonitrile-water (85:15) at a flow rate of 0.2–1.2 mL min-1.
Valacyclovir hydrochloride were measured using UV detection at 265 nm. The total chromatographic
run-time was 10 min with Valacyclovir hydrochloride eluting at 4.19 min. Limit of quantification was
50 ng mL-1. The linearity range of the method was 50-2000 ng mL-1 (r2 = 0.9987). Mean recoveries
from plasma were 105.13%. Intra-batch and inter-batch precision was 0.857 and 0.842, respectively.
The Freeze and Thaw Stability , Short-Term Temperature Stability , Long-Term Stability, Stock
Solution Stability evaluation indicated no evidence of degradation of Valacyclovir hydrochloride. The
validated method is simple, selective and rapid and can be used for pharmacokinetic study.