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Determination of Vardenafil in pharmaceutical formulation by HPLC using conventional C18 and monolithic silica columns

Citation

Aboul-Enein, HY and Ghanem, A and Hoenen, H, Determination of Vardenafil in pharmaceutical formulation by HPLC using conventional C18 and monolithic silica columns, Journal of Liquid Chromatography and Related Technologies, 28, (4) pp. 593-604. ISSN 1082-6076 (2005) [Refereed Article]


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The definitive published version is available online at: http://www.tandf.co.uk/journals

Official URL: http://www.tandf.co.uk/journals

DOI: doi:10.1081/JLC-200047217

Abstract

A simple HPLC analysis for the identification and quantification of vardenafil in a pharmaceutical tablet formulation was performed on a conventional C18 and Chromolith Performance RP-18e monolithic columns with acetonitrile-phosphate buffer mixtures as mobile phases. The effects of the proportion of organic solvent (from 20% to 90%), phosphate buffer pH (from 2 to 7.5) and flow rate (from 1 to 5 mL/min) were studied. The best chromatographic conditions were 20:80 (v/v) acetonitrile-10 mM phosphate buffer, pH 3.0, as mobile phase at 1 mL/min flow rate for the C18 column, whereas 30:70 (v/v) acetonitrile-10 mM phosphate buffer, pH 3.0, as mobile phase at 2 mL/min flow rate was best for the monolithic column. Methanol was found to be a suitable solvent for extraction of the active substance from tablets. For the C18 and monolithic column, the calibration plots were linear (R2 = 0.9996 and 0.9997, respectively) in the concentration range 10-1000 g/mL. Limit of detection (LOD) and limit of quantification (LOQ) values were 0.10 and 0.31 g/mL for the C18 and 0.11 mL and 0.32 g/mL for the monolithic column. Intra-assay and inter-assay precision studies reflected a high level of reliability and reproducibility of the method. The proposed method is selective, precise (RSD = 0.45%), and accurate (recovery = 103-107%) in both columns used.

Item Details

Item Type:Refereed Article
Keywords:liquid chromatography, monolithic column, pharmaceutical preparation, Vardenafil
Research Division:Chemical Sciences
Research Group:Analytical Chemistry
Research Field:Separation Science
Objective Division:Expanding Knowledge
Objective Group:Expanding Knowledge
Objective Field:Expanding Knowledge in the Chemical Sciences
Author:Ghanem, A (Dr Ashraf Ghanem)
ID Code:58307
Year Published:2005
Web of Science® Times Cited:10
Deposited By:Austn Centre for Research in Separation Science
Deposited On:2009-09-25
Last Modified:2012-11-19
Downloads:1 View Download Statistics

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