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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 µg/mL. Limit of detection (LOD) and limit of quantification (LOQ) values were 0.10 and 0.31 µg/mL for the C18 and 0.11 mL and 0.32 µg/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 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
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