Development and Validation of Bioanalytical Method for The Determination of Valcyclovir HCl in Human Plasma by Liquid Chromatoghraphy

[摘要] Valacyclovir hydrochloride (2-[(2-Amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxyl]ethyl ester-l-valine 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, 5.0μm) column, using isocratic elution (acetonitrile-water (85:15) at a flow rate of 0.2–1.2 ml/min. 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 50ng/ml. The linearity range of the method was 50-2000 ng/ml (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.

[学科分类] 分析化学

[关键词] Valacyclovir hydrochloride; Human plasma; Stability