生物学的同等性とバイオアベイラビリティのジャーナル

概要

Validated HPLC Method for the Determination of JWU1497 in Rat Plasma and Its Application to a Comparative Pharmacokinetic Study of the Free Base and Hydrophosphate Salt Forms of JWU1497

Tae Kon Kim and Oui Hyun Jung

In this study, a sensitive and reliable method for the quantitation of JWU1497 in rat plasma was developed and validated using high performance liquid chromatography (HPLC). The pharmacokinetics of 2 forms of JWU1497, namely the base form and the hydrophosphate salt form, were investigated in rats. The 2 forms were orally administered to rats and the plasma concentrations of JWU1497 were determined using HPLC. The JWU1497 base and hydrophosphate salt forms showed similar pharmacokinetic profiles in terms of their maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC). The time to peak concentration (Tmax) of the base form was slightly greater than that of the salt form, but this difference was not statistically significant. These results suggest that the JWU1497 base and hydrophosphate forms are pharmacokinetically equivalent in rats, and thus the base form could be used in various JWU1497 formulations as a substitute for the existing JWU1497 hydrophosphate form.