Analytical method development and validation for simultaneous estimation of sildenafil and dapoxetine in bulk and pharmaceutical dosage form by RP-HPLC method

摘要

A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Sildenafil and Dapoxetine in pharmaceutical dosage form. The column used was Kromasil C18(150mm x 4.6 mm, 5mm) in isocratic mode, with mobile phase containing phosphate buffer(accurately weighed 1.36gm of Potassium dihydrogen Ortho phosphate in a 1000ml of Volumetric flask add about 900ml of milli-Q water added and degas to sonicate, add 0.5ml of Triethylamine, finally made up the volume with water and pH adjusted to 3.5 with dil. orthophosphoric acid) and acetonitrile(42:58 v/v). The flow rate was 1.0ml/ min and effluents were monitored at 293nm. The retention times of Sildenafil and Dapoxetine were found to be 2.813mins and 4.447mins, respectively. The linearity for Sildenafil and Dapoxetine were in the range of 25-150 μg/ml and 15- 90 μg/ml respectively. The recoveries of Sildenafil and Dapoxetine were found to be 98.52 to 100.54% and 98.61 to 100.43%, respectively. The proposed method was validated and successfully applied to the estimation of Sildenafil and Dapoxetine in combined tablet dosage forms.