RP-HPLC method development and validation for determination of dissolution and assay of sildenafil citrate tablets

Journal of Pharmacy Research 01/2010;
Source: DOAJ

ABSTRACT The aim of this study is to development and validation of a stability indicating RP-HPLC method for the determination of dissolution and assay of Sildenafil citrate tablets 50mg and 100mg using RP-HPLC with UV detector. Sildenafil citrate and related substances were baseline separated and quantitated on a C18 reverse phase column (4.6mm × 250mm, 5.0µm), using a mobile phase composed of a phosphate buffer-acetonitrile (40:60v/v,) delivered at a flow rate of 1.0mL/min, and with UV detection (lexcitation = 225nm). The method was proven to be linear over a Sildenafil citrate concentration range of 13 to 83µg/mL with a mean correlation coefficient of 0.9999.