HPLC method for the determination of penciclovir in human plasma and application to a bioequivalence study

Abstract

A simple, specific, and accurate high-performance liquid chromatographic method, using UV detection for the determination of penciclovir in human plasma, is described. Chromatographic separation is performed on a BDS-C18 column using a mixture of phosphate buffer (20mM, pH adjusted to 7.5 with phosphoric acid), methanol, and acetonitrile (94:3:3, v/v/v) as mobile phase. The wavelength of the UV detector is set at 254 nm. The flow-rate is 1.0 mL/min. The assay is linear over the concentration range of 0.1-5.0 μg/mL for penciclovir (r > 0.9996). The limit of quantitation for penciclovir in human plasma is 0.1 μg/mL. The relative standard deviation is less than 7.0% for all the analytes. The method is successfully applied to a randomized crossover bioequivalence study of two different famciclovir capsules in 20 healthy volunteers.