Journal : Acta Chromatographica
Article : Multi-response optimization of a capillary electrophoretic method for determination of vardenafil in the bulk drug and in a tablet formulation

Authors :
Sherma, J.
Department of Chemistry, Lafayette College, Easton, PA 18042, USA,
Vrchotová, N.
Institute of Systems Biology and Ecology AS CR, Branišovská 31, 370 05 České Budějovice, Czech Republic,
Sivakumar, T.
Department of Pharmacy, Faculty of Engineering and Technology, Annamalai University, Annamalainagar, Tamil Nadu-608 002, India,
Petruczynik, A.
Department of Inorganic Chemistry, Medical University, Staszica 6, 20-081 Lublin, Poland,
Benkő, B.
PhD School of Semmelweis University, 1085 Budapest, Üllői út 26, Hungary, Division of Pharmacology and Drug Safety, Richter Gedeon Rt., Gyömrői út 21, 1475 Budapest, P.O. Box 27, Hungary, Department of Chemistry and Biochemistry, University of Pécs, Péc,
Mori, M.
Department of Chemistry, Faculty of Engineering, Gunma University, 1-5-1 Tenjin-cho, Kiryu, 376-8515, Japan,
Solangi, A. R.
National Center of Excellence in Analytical Chemistry, University of Sindh, Jamshoro, Pakistan,
Idris, A. M.
Department of Chemistry, College of Science, King Faisal University, Hofuf 31982, Saudi Arabia,
Abstract : Capillary electrophoresis (CE) with diode-array detection has been used to develop a simple and rapid method for assay of vardenafil in the bulk drug and in a tablet formulation. Multi-response optimization of sensitivity, speed, repeatability of peak height and migration time, and their relative standard deviation (RSD; n = 5), was performed. Electrophoretic factors assumed to be independently affecting the analysis were optimized by use of factorial design and response-surface methods. Other factors were optimized by the univariant method. The optimum conditions were: running buffer 100 mM phosphate, pH 6, injection time 8 s, column temperature 25°C, separating potential 25 kV, column length 31.2 cm, and detection at 222 nm. The method was validated in the presence of the excipients iden-tified by the manufacturer of the tablets (Levitra). Good analytical data were obtained, including linear range 0.5–75 µg mL.1, recovery 98.8%, re-peatability (as RSD) 1.3% (seven consequent injections on the same day), intermediate precision (as RSD) 3.4% (five injections over a week), and li-mits of detection and quantification 0.042 and 0.140 µg mL.1, respectively. Selectivity was assessed in relation to the other, structurally related, drug commonly used to treat erectile dysfunction (sildenafil); sufficient separation was achieved.

Keywords :
Publishing house : University of Silesia in Katowice
Publication date : 2007
Number : No. 19
Page : 97 – 109

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Qute : Sherma, J. ,Vrchotová, N. ,Sivakumar, T. ,Petruczynik, A. ,Benkő, B. ,Mori, M. ,Solangi, A. R. ,Idris, A. M. ,Idris, A. M. , Multi-response optimization of a capillary electrophoretic method for determination of vardenafil in the bulk drug and in a tablet formulation. Acta Chromatographica No. 19/2007