Evaluation of a capillary electrophoresis method for routine determination of varenicline tartrate in quality control laboratories

Mustafa Celebier, Engin Koçak, Sacide Altınöz


In this study, analyses were carried out in a fused-silica capillary (i.d. 50.0 µm, total length 48.5 cm and effective length 40.0 cm), in normal mode, applying a voltage of 20 kV. Sample injections were made in a hydrodynamic mode over 7 seconds under a pressure of 50 mbar. Capillary temperature was set at 35 °C and the detection was performed at 205 nm wavelenght. Background electrolyte was 40 mM citrate buffer at pH 6.0 and the internal standard was labetalol HCl. Total analysis time was shorter than 5 minutes. The method was validated according to the ICH guidelines and it was found to be linear, precise, accurate, specific, robust and rugged. Linearity range was found to be 1.0 – 60.0 µg mL-1 and the limit of detection and quantitation were found as 0.5 and 1.0 µg mL-1, respectively. 



Capillary electrophoresis; varenicline tartrate; analytical method validation; pharmaceutical dosage forms; quality control

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G.M. Keating, M.A. Siddiqui, Varenicline: a review of its use as an aid to smoking cessation therapy, CNS drugs, 20, 945-960 (2006).

K.B. Mihalak, F.I. Carroll, C.W. Luetje, Varenicline is a partial agonist at alpha4beta2 and a full agonist at alpha7 neuronal nicotinic receptors, Molecular pharmacology, 70, 801-805 (2006).

R. Niaura, C. Jones, P. Kirkpatrick, Varenicline, Nature reviews. Drug discovery, 5, 537-538 (2006).

W. Thormann, J. Caslavska, Capillary electrophoresis in drug analysis, Electrophoresis, 19, 2691-2694 (1998).

L. Suntornsuk, Capillary electrophoresis in pharmaceutical analysis: A survey on recent applications, Journal of chromatographic science, 45, 559-577 (2007).

U. Holzgrabe, D. Brinz, S. Kopec, C. Weber, Y. Bitar, Why not using capillary electrophoresis in drug analysis?, Electrophoresis, 27, 2283-2292 (2006).

Web Page http://www.who.int/medicines/areas/quality_safety/quality_assurance/control/en/index.html

J. Plotka, M. Tobiszewski, A.M. Sulej, M. Kupska, T. Gorecki, J. Namiesnik, Green chromatography, J. Chromatogr. A, 1307, 1-20 (2013).

A.A. Kadi, M.S. Mohamed, M.G. Kassem, I.A. Darwish, A validated stability-indicating HPLC method for determination of varenicline in its bulk and tablets, Chemistry Central Journal, 5, (2011).

S.S. Pujeri, A.M.A. Khader, J. Seetharamappa, Stress degradation studies on varenicline tartrate and development of a validated stability-indicating HPLC method, Sci. Pharm., 80, 115-126 (2012).

P. Katakam, R.R. Kalakuntla, S. Jaypal Reddy, A novel stability indicating RP-HPLC assay method for the determination of varenicline in pharmaceutical formulations, Pharmacologia, 3, 169-173 (2012).

A.A. Kadi, M.S. Mohamed, M.G. Kassem, I.A. Darwish, A validated stability-indicating HPLC method for determination of varenicline in its bulk and tablets, Chem. Cent. J., 5, 30 (2011).

K.P. Channabasavaraj, J.S. Modiya, H.M. Sharath, Development and validation of RP-HPLC method for estimation of varenicline tartrate in bulk drug and tablet dosage form, Int. J. Pharm. Pharm. Sci., 3, 59-61 (2011).

B. Satheesh, S. Kumarpulluru, V. Raghavan, D. Saravanan, UPLC separation and quantification of related substances of varenicline tartrate tablet, Acta Chromatogr., 22, 207-218 (2010).

E. Kocak, M. Celebier, S. Altinoz, Validation of spectrophotometric method to quantify varenicline content in tablets, Asian J. Chem., 25, 1845-1848 (2013).

M.M. Aleksic, V. Radulovic, N. Lijeskic, V. Kapetanovic, Electrochemical Response and Determination of Varenicline at Boron Doped Diamond, Glassy Carbon and Hanging Mercury Electrodes, Current Analytical Chemistry, 8, 133-142 (2012).

H.A. Alhazmi, H.A. Makeen, S. El Deeb, Determination of Varenicline by Capillary Zone Electrophoresis, Digest Journal of Nanomaterials and Biostructures, 8, 295-300 (2013).

S.P. Sudhakar, A.M.A. Khader, J. Seetharamappa, Stress Degradation Studies on Varenicline Tartrate and Development of a Validated Stability-Indicating HPLC Method, Sci. Pharm, 80, 115-126 (2012).

M.A. Hayes, I. Kheterpal, A.G. Ewing, Effects of buffer pH on electroosmotic flow control by an applied radial voltage for capillary zone electrophoresis, Anal Chem, 65, 27-31 (1993).

H. Celik, M. Buyukaga, M. Celebier, E.T. Acar, M.S. Baymak, N. Gokhan-Kelekci, E. Palaska, H. Erdogan, Determination of pK(a) Values of Some Benzoxazoline Derivatives and the Structure-Activity Relationship, Journal of Chemical and Engineering Data, 58, 1589-1596 (2013).

G.A. Caliaro, C.A. Herbots, Determination of pK(a) values of basic new drug substances by CE, J. Pharm. Biomed. Anal., 26, 427-434 (2001).

X.C. Xuan, D.Q. Li, Joule heating effects on peak broadening in capillary zone electrophoresis, J. Micromech. and Microeng., 14, 1171-1180 (2004).

ICH Guideline. Q2 (R1): Validation of Analytical Procedure: Text and Methodology. ICH, London; 2005 (in English)

DOI: http://dx.doi.org/10.20450/mjcce.2015.508


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