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Spectrophotometric Bivariate Method for Determination of Candesartan Cilexetil in Presence of its Alkaline Induced Degradation Product
Corresponding Author(s) : Wedad Al-Onazi
Asian Journal of Chemistry,
Vol. 25 No. 2 (2013): Vol 25 Issue 2
Abstract
A simple, sensitive, selective and precise stability -indicating method for the determination of candesartan cilexetil in presence of its alkaline degradate and in tablets was developed and validated. The method is based on determination of candesartan cilexetil by the bivariate calibration depending on simple mathematic algorithm which provide simplicity and rapidity. The method showed good linearity in the range of 1- 12 μg mL-1 at 225 and 2-12 μg mL-1 at 250 nm with mean percentage recovery 100.29 ± 0.64. Candesartan cilexetil can be determined in the presence of up to 80 % of its alkaline degradate, the selectivity of the method was checked using laboratory prepared mixtures. The proposed method has been successfully applied to the analysis of candesartan cilexetil in bulk and in commercial tablets without interference from additives or excipients and the results were satisfactory compared with a reference method. Also, the suggested method was successfully applied to the content uniformity testing and degradation kinetic study.
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References
K.L. McClellan and K.I. Goa, Drugs, 56, 847 (1998).
C.H. Gleiter, C. Jagle, U. Gresser and K. Morike, Cardiovas. Drugs Rev., 22, 263 (2004).
N. Ferreiros, S. Dresen, R.M. Alonso and W. Weinmann, J. Chromatogr. B, 855, 134 (2007).
L. Gonzalez, J.A. Lopez, R.M. Alonso and R.M. Jimenez, J. Chromatogr. A, 949, 49 (2002).
G. Iriarte, O. Gonzalez, N. Ferreiros, M.I. Maguregui, R.M. Alonso and R.M. Jimemez, J. Chromatogr. B, 877, 3045 (2009).
O. Gonzalez, G. Iriarte, N. Ferreiros, M.I. Maguregui, R.M. Alonso and R.M. Jimenez, J. Pharm. Biomed. Anal., 50, 630 (2009).
S. Mehta, R.P. Shah, R. Priyadarshi and S. Singh, J. Pharm. Biomed. Anal., 52, 345 (2010).
D.V.S. Roa, P. Radhakrishnanand, M.V. Suryanarayana and V. Himabindu, Chromatographia, 66, 499 (2007).
L.-J. Zhou, W. Dai, L.-H. Gu, Y.-J. Wang, Z.-Y. Huang and J.-Y. Liang, Fudan Univ. J. Med. Sci., 35, 552 (2008).
H. Stenhoft, P.O. Lagerstrom and C. Andersen, J. Chromatogr. B, 731, 411 (1999).
N. Erk, J. Liq. Chromatogr. Rel. Technol., 26, 2581 (2003).
S.S. Qutab, S.N. Razzaq, M. Asfag, Z.A. Shuja and I.U. Khan, Acta Chromatogr., 19, 119 (2007).
A.E.M. Khedr, King Abdulaziz Univ. Med. Sci., 15, 3 (2008).
S. Hillaert and W. Van den Bossche, J. Chromatogr. A, 979, 323 (2002).
S. Hillaert and W. Van den Bossche, J. Pharm. Biomed. Anal., 31, 329 (2003).
S. Hillaert, T.R.M. De Beer, J.O. De Beer and W. Van den Bossche, J. Chromatogr. A, 984, 135 (2003).
M. Zhang, F. Wei, Y.F. Zhang, J. Nie and Y.Q. Feng, J. Chromatogr. A, 1102, 294 (2006).
B. Dogan, B. Uslu and S.A. Ozkan, Pharmazie, 59, 840 (2004).
I. Suslu, N. OzaltIn and S. AltInoz, J. Appl. Electrochem., 39, 1535 (2009).
I. Suslu, N. OzaltIn and S. AltInoz, J. Assoc. Off. Anal. Chem. Int., 93, 562 (2010).
B.H. Mehta and S.B. Morge, J. Planar Chromatogr. Modern TLC, 21, 173 (2008).
N.A. Charoo, M. Bashir, E. Abdalla and K.I.H. Ali, Anal. Lett., 42, 2232 (2009).
N. Erk, Pharmazie, 58, 796 (2003).
M. Stolarczyk, A. Maslanka, J. Krzek and J. Milczarek, Acta Poloniae Pharm. Drug Res., 65, 275 (2008).
ICH, Stability Testing of New Drugs Substances and Products International Conference on Harmonization, Geneva (1993).
P.L. Lopez-deAlba, L.L. Martinez, K.W. Kaczmarmarzyc, K. Wrobel and J.A. Hernandez, J. Anal. Lett., 29, 487 (1996).
P.L. Lopez-de-Alba, L.L. Martinez, K.W. Kaczmarmarzyc, K. Wrobel and J.A. Hernandez, Bol. Soc. Chilena Quim, 41, 111 (1996).
D.L. Massart, B.G.M. Vandeginste, S.N. Deming, Y. Michotte and L. Kaufman, Chemometrics A Textbook, Elsevier, Amsterdam, p. 124 (1988).
F.H. Metwally, Spectrochim. Acta A, 69, 343 (2008).
ICH.Q2 (R1) Validation of Analytical Procedures: Test and Methodology, International Conference on Harmonization, Geneva (2005).
J.C. Miller and J.N. Miller, Statistics for Analytical Chemistry, EllisHowood New York, edn. 4, p. 115 (1993).
The United States Pharmacopeia 30, The National Formulary, 25, (2007):US Pharmacopeial Convention; Rockville, MD, Electronic version.
K.A. Conners, G.L. Amidon and L. Kennon, In Chemical Stability of Pharmaceuticals, John Wiley & Sons, New York, p. 20 (1979).