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

Hassan Y. Aboul-Enein, Ashraf Ghanem, Hubert Hoenen

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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.

Original languageEnglish
Pages (from-to)593-604
Number of pages12
JournalJournal of Liquid Chromatography and Related Technologies
Issue number4
Publication statusPublished - 2005
Externally publishedYes


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