Determination of SK&F 108566 (Teveten) 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 its internal standard (SB-200062) from plasma samples. The assay is based on analysis by reversed-phase high-performance liquid chromatography with ultraviolet absorbance detection. The dynamic range of the assay is from 10.0 to 5000 ng/ml, based on 0.5-ml aliquots of plasma. No interference from the endogenous components of plasma, 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 was found to be stable in plasma under the storage and sample preparation conditions used. This assay has been successfully employed to provide pharmacokinetic data from clinical trials.