Determination of SK3497 in rat plasma and its application in a pharmacokinetic study of SK3497

In this study, a sensitive and reliable method for the quantitation of SK3497 in rat plasma was developed and validated using high performance liquid chromatography. The plasma samples were prepared by deproteinization, and sildenafil was used as an internal standard. Chromatographic separation was achieved using a reversed-phase (C18) column. The mobile phase, 0.02 M ammonium acetate buffer:acetonitrile (45:55, v/v), was run at a flow rate of 1.0 mL/min, and the column eluent was monitored using an ultraviolet detector at 254 nm at room temperature. The retention times of sildenafil (an internal standard), and SK3497 were approximately 5.6 and 8.3 min, respectively. The detection limit of SK3497 in rat plasma was 0.03 μg/mL. Pharmacokinetic parameters of SK3497 was evaluated after intravenous (i. v.; at doses of 15 mg/kg) and oral (p.o.; at doses of 30 mg/kg) administration of SK3497 in rats. After p.o. administration (30 mg/kg) of SK3497, F-value was approximately 53.0%. The protein binding of SK3497 to 4% human serum albumin were also described.