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

Author(s): Useni Reddy Mallu1 K. Hussain Reddy1, Varaprasad Bobbarala2*, Somasekhar Penumajji2

Journal: Journal of Pharmacy Research
ISSN 0974-6943

Volume: 3;
Issue: 3;
Start page: 631;
Date: 2010;
Original page

Keywords: Sildenafil citrate | pulmonary arterial hypertension | RP-High performance liquid chromatography (RP-HPLC).

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.

Tango Jona
Tangokurs Rapperswil-Jona

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