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Sensitive Liquid Chromatographic Assay for Simultaneous Determination of Olmesartan and Its Prodrug Olmesartan Medoxomil in Rabbit Plasma
Corresponding Author(s) : T. Sharma
Asian Journal of Chemistry,
Vol. 26 No. 12 (2014): Vol 26 Issue 12
Abstract
A rapid, sensitive, precise and accurate reverse phase liquid chromatographic (RP-HPLC) method was developed and validated for olmesartan and its prodrug olmesartan medoxomil in rabbit plasma. The method was developed on symmetry C18 column (4.6 mm × 150 mm, 5 μm) using a mobile phase of acetonitrile: 0.1 % aqueous triethylamine adjusted to pH 6 with orthophosphoric acid (90:10 v/v). The peaks were eluted at 254 nm wavelength and no interferences found from plasma. The total run time was 10 min with a flow rate of 1 mL/min. Calibration plots were linear over the range of 2-100 ng/mL for olmesartan medoxomil and 0.5-20 ng/mL for olmesartan. Retention time of olmesartan medoxomil, olmesartan and internal standard (irbesartan) were 3.23, 4.85 and 6.90 min, respectively. The method has been successfully applied to pharmacokinetic studies of olmesartan medoxomil and olmesartan in rabbits. The results demonstrated that olmesartan medoxomil was rapidly and totally converted to its parent drug, olmesartan following oral administration. Olmesartan medoxomil is a prodrug of olmesartan.
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- S.-F. Ma, M. Anraku, Y. Iwao, K. Yamasaki, U. Kragh-Hansen, N. Yamaotsu, S. Hirono, T. Ikeda and M. Otagiri, Drug Metab. Dispos., 33, 1911 (2005); doi:10.1124/dmd.105.006163.
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- T. Ikeda, In Proceedings of the International Symposium on Serum Albumin & α1-Acid Glycoprotein: Two Prodrugs Activated by Serum Esterases including Albumin, pp. 173-180 (2000).
- V.V. Vaidya, S.M.N. Roy, S.M. Yetal, S.S. Joshi and S.A. Parekh, Chromatographia, 67, 147 (2008); doi:10.1365/s10337-007-0453-x.
- T. Murakami, H. Konno, N. Fukutsu, M. Onodera, T. Kawasaki and F. Kusu, J. Pharm. Biomed. Anal., 47, 553 (2008); doi:10.1016/j.jpba.2008.02.021.
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- T. Sharma, S.C. Si and D.G. Sankar, J. Pharmacy Res., 3, 1553 (2010).
- T. Sharma, N. Mishra, S.C. Si and D.G. Sankar, Der Pharm. Lett., 2, 302 (2010).
- N. Shah, B. Suhagia, R. Shah and N. Patel, Indian J. Pharm. Sci., 69, 834 (2007); doi:10.4103/0250-474X.39447.
- M. Celebier and S. Altinoz, Hacettepe Univ. J. Faculty of Pharmacy, 27, 119 (2007).
- C.V. Patel, A.P. Khandhar, A.D. Captain and K.T. Patel, Eurasian J. Anal. Chem., 2, 159 (2007).
- P.D. Bari and A.R. Rote, Chromatographia, 69, 1469 (2009); doi:10.1365/s10337-009-1094-z.
- O. Sagirli, A. Önal, S.E. Toker and D. Şensoy, Chromatographia, 66, 213 (2007); doi:10.1365/s10337-007-0304-9.
- ICH, Validation of Analytical Procedures: Text and Methodology Q1A(R2); International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, (2005).
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- British Pharmacopoeia, Her Majesty Stationary Office, London, 2144 (II), (2001).
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References
S.-F. Ma, M. Anraku, Y. Iwao, K. Yamasaki, U. Kragh-Hansen, N. Yamaotsu, S. Hirono, T. Ikeda and M. Otagiri, Drug Metab. Dispos., 33, 1911 (2005); doi:10.1124/dmd.105.006163.
H. Koike, T. Sada and M. Mizuno, J. Hypertens. Suppl., 19, S3 (2001); doi:10.1097/00004872-200106001-00002.
J. Neutel, Am. J. Cardiol., 87, 37C (2001); doi:10.1016/S0002-9149(01)01510-7.
J. Brousil and J. Burke, Clin. Ther., 25, 1041 (2003); doi:10.1016/S0149-2918(03)80066-8.
P. Laeis, K. Puchler and W. Kirch, J. Hypertens., 19, S21 (2001); doi:10.1097/00004872-200106001-00004.
T. Ikeda, In Proceedings of the International Symposium on Serum Albumin & α1-Acid Glycoprotein: Two Prodrugs Activated by Serum Esterases including Albumin, pp. 173-180 (2000).
V.V. Vaidya, S.M.N. Roy, S.M. Yetal, S.S. Joshi and S.A. Parekh, Chromatographia, 67, 147 (2008); doi:10.1365/s10337-007-0453-x.
T. Murakami, H. Konno, N. Fukutsu, M. Onodera, T. Kawasaki and F. Kusu, J. Pharm. Biomed. Anal., 47, 553 (2008); doi:10.1016/j.jpba.2008.02.021.
V.P. Rane, K.R. Patil, J.N. Sangshetti, R.D. Yeole and D.B. Shinde, Chromatographia, 69, 169 (2009); doi:10.1365/s10337-008-0849-2.
L. Bajerski, C. Paim, A. Pereira, C. Dias, R. Rossi, V. Todeschini, M. Steppe, A. Bergold and P. Fröehlich, Quim. Nova, 36, 34 (2013); doi:10.1590/S0100-40422013000100007.
D. Liu, P. Hu, N. Matsushima, X. Li, L. Li and J. Jiang, J. Chromatogr. B, 856, 190 (2007); doi:10.1016/j.jchromb.2007.05.049.
T. Sharma, S.C. Si and D.G. Sankar, J. Pharmacy Res., 3, 1553 (2010).
T. Sharma, N. Mishra, S.C. Si and D.G. Sankar, Der Pharm. Lett., 2, 302 (2010).
N. Shah, B. Suhagia, R. Shah and N. Patel, Indian J. Pharm. Sci., 69, 834 (2007); doi:10.4103/0250-474X.39447.
M. Celebier and S. Altinoz, Hacettepe Univ. J. Faculty of Pharmacy, 27, 119 (2007).
C.V. Patel, A.P. Khandhar, A.D. Captain and K.T. Patel, Eurasian J. Anal. Chem., 2, 159 (2007).
P.D. Bari and A.R. Rote, Chromatographia, 69, 1469 (2009); doi:10.1365/s10337-009-1094-z.
O. Sagirli, A. Önal, S.E. Toker and D. Şensoy, Chromatographia, 66, 213 (2007); doi:10.1365/s10337-007-0304-9.
ICH, Validation of Analytical Procedures: Text and Methodology Q1A(R2); International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, (2005).
ICH, Validation of Analytical Procedures: Text and Methodology Q2B; International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, (2005).
British Pharmacopoeia, Her Majesty Stationary Office, London, 2144 (II), (2001).
USP, The United States Pharmacopoeia, United States Pharmacopoeia Convention: Rockville, edn 35 (2012).
FDA/CDER, Guidance for the Industry: Bioanalytical Method Validation, Department of Health and Human Services, US Food and Drug Administration, Centre for Drug Evaluation and Research (CDER) website. Available from: /http://www.fda.gov/cder/guidance/4252fnl.pdf (2001).