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

Abstract

This study was aimed at develop and validate RP-HPLC method for the assay of sildenafil citrate in tablets' formulation. A chromatographic system comprising Partisil 10 ODS C18 (250 × 4.6 mm, 5µm) column, a mobile phase of Buffer solution (pH 2.0): acetonitrile, a flow rate of 1.5 ml/min and a UV detector set at 228 nm has shown good chromatographic separation for sildenfil. The degree of lineratity of the calibration curves, the percent recoveries of sildenafil and related substances, the limit of detection (LOD), and limit of quantitation (LOQ) for the HPLC method have been determined. The HPLC method under study was found to be specific, precise, accurate, reproducible indicating stability and robust.