Short Communication

DETERMINATION OF PHARMACOKINETIC PARAMETERS OF SILDENAFIL IN IRANIAN VOLUNTEERS BY AN HPLC METHOD

  • Massoud MAHMOUDIAN
  • Hamidreza FALAHATPISHE
  • Ladan TAYEBI
  • Ebadollah SALEK MOGHADAM
  • Babak GHOLAMINE

Received Date: 25.12.2008 Accepted Date: 11.06.2009 Turk J Pharm Sci 2010;7(1):69-74

Pharmacokinetic parameters of sildenafil in Iranian volunteers were determined by using a simple, rapid and sensitive HPLC-UV method. The assay procedure involves extraction of sildenafil in basic pH with dichloromethane. After evaporation of dichloromethane under a steam of nitrogen; the residue was dissolved in 0.2 mL of mobile phase. The mobile phase consists of acetonitrile - KH2P04 (30 mM) (56:44, v/v). The column was RPC18 and flow rate was 1.0 mL/min. at ambient temperature (25°C). Peaks were monitored by UV detector set at 290 nm. Chlordiazepoxide was used as internal standard (IS). The peak areas of sildenafil/lS ratio versus drug concentrations relationship was linear (r>0.992). The extraction efficiency was 92%. The minimum quantifiable concentration was found to be 10 ng/mL. The method was used to determination of plasma concentrations. 2x50 mg of Viagra tablets were administered toll healthy male volunteers and sildenafil was determined in the plasma and pharmacokinetic parameters of sildenafil (Ke, Tmax, T1/2, Cmax and AUC) were calculated.

Keywords: Sildenafil, HPLC, Pharmacokinetics