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Ultra Performance Liquid Chromatographic Method for the Determination of Cetirizine Dihydrochloride in Commercial Pharmaceutical Liquid Formulation
Corresponding Author(s) : Saadet Dermis
Asian Journal of Chemistry,
Vol. 25 No. 3 (2013): Vol 25 Issue 3
Abstract
A new ultra performance liquid chromatographic method was developed for the determination of cetirizine hydrochloride in pharmaceutical liquid formulation. The chromatographic separation was achieved on aquity ultra performance liquid chromatographic BEH C18 (100 × 2.1 mm, 1.7 μm) column and a mobile phase consisting of a water:acetonitrile (50:50, v/v). The flow rate was 0.3 mL min-1 and the detection wavelength was 235 nm. The ultra performance liquid chromatographic method shows excellent linearity over a range of 4 μg mL-1 to 28 μg mL-1. The correlation coefficient for the cetirizine hydrochloride the linear regression equation was more than 0.999. The limit of detection and the limit of quantification for cetirizine hydrochloride were found as 0.39 and 1.30 μg mL-1, respectively. This chromatographic method was validated by using validation parameters. The proposed chromatographic method can be applied to the quality control and routine analysis of cetirizine hydrochloride in pharmaceutical liquid formulation.
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- S.C. Sweetman, Martindale, The Complete Drug Reference, The Phamaceutical Press, London, edn. 33, p. 411 (2002)
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- A.M.Y. Jaber, H.A. Al-Sherife, M.M. Al-Omari and A.A. Badwan, J. Pharm. Biomed. Anal., 36, 341 (2004).
- O.C. Sun, H.L. Seok, S.K. Hak, J.K. Eun and P.C. Hae-Young, J. Chromatogr. B., 744, 201 (2000).
- M.T. Rosseel and R.A. Lefebvre, J. Chromatogr., 565, 504 (1991).
- S. Rudaz, S. Souverain, C. Schelling, M. Deleers, A. Klomp, A. Norris, T.L. Vu, B. Ariano and J.L. Veuthey, Anal. Chim. Acta, 492, 271 (2003).
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- M. Peter, V. Iva and H. Emil, J. Sep. Sci., 28, 1278 (2005).
- S.D. Güngör, Die Pharmazie, 59, 929 (2004).
- International Conference on Harmonization. Validation of Analytical Procedure, Text and Methodology Q2(R1). IFPMA, Geneve, Switzerland (2005).
References
S.C. Sweetman, Martindale, The Complete Drug Reference, The Phamaceutical Press, London, edn. 33, p. 411 (2002)
Reminghton: The Science and Practice of Pharmacy. Lippincott Williams and Wilkins, Philadelphia, edn. 21 (2006).
European Medicines Agency. Guideline on Excipients in the Dossier for Application for Marketing Authorization of a Medicinal Product, Doc. Ref. EMEA/CHMP/QWP/396951/2006. London, 6 November.
M.S. Prakash, M. Sundarapandian, S. Meena and M.S. Nagarjan, Indian Drug, 37, 211 (2000).
K.C. Ramesh, M.B. Melwanki, B.G. Gowda, J. Seetharamappa and J. Keshavayya, Indian J. Pharm. Sci., 64, 455 (2002).
A.F.M. El Walily, M.A. Korany, A. El Gindy and M.F. Bedair, J. Pharm. Biomed. Anal., 17, 435 (1998).
M.F. Zaater, Y.R. Tahboub and N.M. Najib, J. Pharm. Biomed. Anal., 22, 739 (2000).
A.M.Y. Jaber, H.A. Al-Sherife, M.M. Al-Omari and A.A. Badwan, J. Pharm. Biomed. Anal., 36, 341 (2004).
O.C. Sun, H.L. Seok, S.K. Hak, J.K. Eun and P.C. Hae-Young, J. Chromatogr. B., 744, 201 (2000).
M.T. Rosseel and R.A. Lefebvre, J. Chromatogr., 565, 504 (1991).
S. Rudaz, S. Souverain, C. Schelling, M. Deleers, A. Klomp, A. Norris, T.L. Vu, B. Ariano and J.L. Veuthey, Anal. Chim. Acta, 492, 271 (2003).
E.A. Van and Y. Michotte, Electrophoresis, 27, 2376 (2006).
M. Peter, V. Iva and H. Emil, J. Sep. Sci., 28, 1278 (2005).
S.D. Güngör, Die Pharmazie, 59, 929 (2004).
International Conference on Harmonization. Validation of Analytical Procedure, Text and Methodology Q2(R1). IFPMA, Geneve, Switzerland (2005).