DETERMINATION OF SK-AND-F-108566 (TEVETEN(R)) IN HUMAN PLASMA BY REVERSED-PHASE HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY

A sensitive, selective and rugged analytical method was developed for the determination of SK&F 108566 (eprosartan, Teveten) in human plasma . the new method employs a simple solid-phase extraction procedure to isolate the drug and it internal standard (SB-200062) from plasma samp les. The assay is based on analysis by reversed-phase high-performance liquid chromatography with ultraviolet absorbance detection. The dyna mic range of the assay is from 10.0 to 5000 ng/ml, based on 0.5-ml ali quots of plasma. No interference from the endogenous components of pla sma, the anticoagulant, or sample collection devices have been noted. The assay has been fully validated. The mean within-run precision (6.5 %), between-run precision (4.0%), accuracy (106%) and recovery (71.8%) of the method were considered acceptable. Additionally, SK&F 108566 w as found to be stable in plasma under the storage and sample preparati on conditions used. This assay has been successfully employed to provi de pharmacokinetic data from clinical trials. (C) 1998 Published by El sevier Science B.V.