A simple, rapid and precise reverse phase high performance liquid chromatographic method was developed for simultaneous estimation of Sildenafil Citrate and Dapoxetine Hydrochloride in tablet dosage form using Kromasil ODS C-18 (5μm), 250 × 4.6 mm reversed-phase column and mobile phase Methanol : Acetonitrile (95:5) with 0.5% Triethylamine in isocratic mode. The flow rate was 1.0 ml/min and individual components were measured at 292 nm. The retention time of Sildenafil Citrate and Dapoxetine Hydrochloride was found to be 3.07 and 4.59 min respectively. The calibration curve was linear over the concentration range of 10-70 µg/ml for Sildenafil Citrate (r2=0.9991) and Dapoxetine Hydrochloride (r2=0.9992). The high percentage of recovery confirms the suitability of the method for the estimation of Sildenafil Citrate and Dapoxetine Hydrochloride in tablet dosage form. The method was validated in terms of accuracy, precision, linearity, limit of detection and limit of quantitation as per ICH guidelines. The procedure was successfully applied for simultaneous determination of both drugs in tablet dosage form.
Loading....