HPLC method for the determination of penciclovir in human plasma and application to a bioequivalence study.
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-C(18) 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 microg/mL for penciclovir (r > 0.9996). The limit of quantitation for penciclovir in human plasma is 0.1 microg/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.
Pan
Yongyu
Y
School of Pharmacy, Shenyang Pharmaceutical University,103 Wenhua Road, Shenyang, Liaoning Province, PR China 110016.
Gao
Xinxing
X
Guo
Na
N
Li
Junming
J
Guo
Xingjie
X
D000212:Acyclovir / Q000031:analogs & derivatives* / Q000097:blood / Q000302:isolation & purification / Q000493:pharmacokinetics; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006147:Guanine; D006801:Humans; D013810:Therapeutic Equivalency
C053539:penciclovir; D006147:Guanine; D000212:Acyclovir