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Determination of Leuprolide in Beagle Dogs' Serum by High Performance Liquid Chromatography-Mass Spectrometry and Study on Bioequivalence
Corresponding Author(s) : X. Bao
Asian Journal of Chemistry,
Vol. 26 No. 8 (2014): Vol 26 Issue 8
Abstract
An HPLC-MS/MS method was used to calculate the pharmacokinetic parameters and to evaluate the bioequivalence versus equal dose of test or reference leuprolide microspheres in male healthy beagle dogs. The MS-MS detection was made by monitoring 605.5®221.3 (m/z) for leuprolide and 584.4®221.3 (m/z) for the I.S. The dynamic range was from 0.103-103 ng mL-1. The recovery rate was 78.75-90.77 % and matrix effect was -5.25-10.3 %. The intra- and inter-assay precisions were with relative standard deviations (RSDs) of £ 5.19 % (n = 6) and £ 6.48 % (n = 6), respectively. Evaluation of bioequivalence was made by analysis of variance, Double-sided t-test and (1-2a) confidence interval method. The results show the test agents, the AUC0®t leuprolide 90 % confidence interval for the reference preparation of the corresponding parameters of 99.6-102.5 %, the AUC0®¥ leuprolide 90 % confidence interval for the reference preparation of the corresponding parameters of 90.2-103.9 %, Cmax 90 % confidence interval for the reference preparation of the corresponding parameters of 91.0-129.8 %.
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- P. Briken, A. Hill and W. Berner, J. Clin. Psychiatry, 64, 890 (2003).
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References
P. Briken, A. Hill and W. Berner, J. Clin. Psychiatry, 64, 890 (2003).
G.L. Plosker and R.N. Brogden, Drugs, 48, 930 (1994); doi:10.2165/00003495-199448060-00008.
W.R. Gombotz and D.K. Pettit, Bioconjug. Chem., 6, 332 (1995); doi:10.1021/bc00034a002.
H. Okada and H. Toguchi, Crit. Rev. Ther. Drug, 12, 1 (1995); doi:10.1615/CritRevTherDrugCarrierSyst.v12.i1.10.
B.H. Woo, B.F. Fink, R. Page, J.A. Schrier, J.W. Jo, G. Jiang, M. DeLuca, H.C. Vasconez and P.P. DeLuca, Pharm. Res., 18, 1747 (2001); doi:10.1023/A:1013382832091.
V.P. Shah, K.K. Midha, J.W.A. Findlay, H.M. Hill, J.D. Hulse, I.J. McGilveray, G. McKay, K.J. Miller, R.N. Patnaik, M.L. Powell, A. Tonelli, C.T. Viswanathan and A. Yacobi, Pharm. Res., 17, 1551 (2000); doi:10.1023/A:1007669411738.
P.J. Taylor, Clin. Biochem., 38, 328 (2005); doi:10.1016/j.clinbiochem.2004.11.007.
Z.D. Sofianos, T. Katsila, N. Kostomitsopoulos, V. Balafas, J. Matsoukas, T. Tselios and C. Tamvakopoulos, J. Mass Spectrom., 43, 1381 (2008); doi:10.1002/jms.1416.
J. Yin, P. Aviles, W. Lee, C. Ly, M.J. Guillen, P. Calvo, I. Manzanares and G. Faircloth, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 794, 89 (2003); doi:10.1016/S1570-0232(03)00418-5.
J.Z. Yang, K.C. Bastian, R.D. Moore, J.F. Stobaugh and R.T. Borchardt, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 780, 269 (2002); doi:10.1016/S1570-0232(02)00536-6.
O.O. Grigoriants, J.L. Tseng, R.R. Becklin and D.M. Desiderio, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 695, 287 (1997); doi:10.1016/S0378-4347(97)00182-5.
Y. Zhan, X.Y. Chen, X.H. Zhao and D.F. Zhong, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 877, 3194 (2009); doi:10.1016/j.jchromb.2009.08.023.