Analytical method development and validation for estimation of sildenafil citrate in tablet dosage form using RP-HPLC

A simple, precise, accurate, reproducible and robust HPLC method was developed for the estimation of sildenafil citrate in pharmaceutical dosage forms. This method was validated as per ICH guidelines. Analysis of drug was performed on Waters X Terra C18 column (250 mm × 4.6 mm × 5?), consisting of mobile phase, employing Phosphate buffer and Acetonitrile (40:60 V/V) as the mobile phase at a flow rate of 1 mL/min. The estimation of drug was carried out at 231 nm using UV detector. The retention time of the sildenafil citrate was found to be 12.38 min. The method produced good linear responses in the concentration range of 2.5 ?g to 37.5 ?g /mL. The % RSD values for system precision and method precision were found to be 0.2 and 0.07 respectively. The proposed method was found to be applicable for determination of the drug in tablet dosage form.