Stereoselective HPLC Assay of T J0711 Enantiomers by Precolumn Derivatization with GITC Using UV Detection and Its Application in Pharmacokinetics in Rats

This investigation describes a new precise, sensitive and accurate stereoselective RP-HPLC method for determination of the enantiomers of a novel α- and β-receptor blocking agent, 1-[4-（2-methoxyethyl） phenoxy]-3-[[2-（2- methoxyphenoxy） ethyl]amino]-2-propanol （T J0711）, in rat plasma. GITC was used for precolunm derivatization of T J0711 enantiomers. Enantiomeric resolution was achieved on a Eurospher-100 C18 column （250 mm×4.6 mm ID, 5-μm particle size）, with UV detection at 255 nm, and the mobile phase consisted of acetonitrile and water （58：42, v/v） containing 0.02% glacial acetic acid （v/v）. Using the chromatographic conditions described, T J0711 enantiomers were well resolved with mean retention time of 10.2 and 11.5 min, respectively. Linear response （r〉0.999） was observed over the range of 0.125-12.5 μg/mL of TJ0711 hydrochloride enantiomers. The mean relative standard deviation （RSD%） of the results of within-day precision was ≤ 10%. The proposed method was found to be suitable and accurate for the quantitative determination of T J0711 enantiomers in rat plasma, and it can be used in pharmacokinetic studies.