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Tytuł artykułu

Development and validation of an RP-HPLC-UV method for the determination of ondansetron in rabbit plasma: Application to a pharmacokinetic study

Autorzy
Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
A new sensitive and specific isocratic RP-HPLC-UV method was developed and validated for the determination of ondansetron in rabbit plasma using risperidone as an internal standard (IS). The sample preparation involved a simple deprotenization procedure with a mixture of 1 mL of acetonitrile and 50 μL of 10% w/υ zinc sulfate. Analysis was performed on a Phenomenex CN column (250 mm × 4.6 mm, 5 μm) with 50 mM ammonium acetate (pH 3.5) and acetonitrile (35:65, υ/υ) as mobile phase at a flow rate of 1.0 mL min-1. Column eluent was monitored at 310 nm. The calibration curve was linear over the concentration range of 25–1000 ng mL-1. (r2 = 0.9999) with a limit of quantification (LOQ) 25 ng mL. -1.The intraday and interday precision and accuracy were between 0.93% and 3.41% and −3.63% and 1.01%, respectively. The mean recoveries of ondansetron and risperidone were 85.87% and 99.80%, respectively. Ondansetroncontaining plasma samples were stable at −20°C for 14 days. The validated method was successfully applied for a pharmacokinetic study after a single oral administration of ondansetron (8 mg) to rabbits.
Rocznik
Strony
579--593
Opis fizyczny
Bibliogr. 18 poz., rys., tab.
Twórcy
autor
  • University Sains Malaysia School of Pharmaceutical Sciences 11800 Penang Malaysia
autor
  • University Sains Malaysia School of Pharmaceutical Sciences 11800 Penang Malaysia
autor
  • University Sains Malaysia School of Pharmaceutical Sciences 11800 Penang Malaysia
Bibliografia
  • [1] Fabi, M. Ciccarese, G. Metro, A. Savarese, D. Giannarelli, C.M. Nuzzo, M. Russillo, I. Sperduti, I. Carbone, E. Bria, and F. Cognetti, Support. Care Cancer, 16, 1375 (2008)
  • [2] S. Ravi, Y. Darwis, and N. Khan, Chromatographia, 70, 75 (2009)
  • [3] M. Depot, S. Leroux, and G. Caille, J. Chromatogr. B, 693, 399 (1997)
  • [4] S. Bauer, E. Stormer, R. Kaiser, P.B. Tremblay, J. Brockmoller, and I. Roots, Biomed. Chromatogr., 16, 187 (2002)
  • [5] D. Chandrasekar, S. Ramakrishna, and P.V. Diwan, Arzneimittel-Forsch., 54, 655 (2004)
  • [6] P.V. Colthup, C.C. Felgate, J.L. Palmer, and N.L. Scully, J. Pharm. Sci., 80, 868 (1991)
  • [7] J.W. Kelly, L. He, and J.T. Stewart, J. Chromatogr., 622, 291 (1993)
  • [8] J. Liu and J.T. Stewart, J. Chromatogr. B, 694, 179 (1997)
  • [9] V. Sutariya and R. Mashru, AAPS Annual Meeting and Exposition (2006)
  • [10] Y.P. Armando, S.G. Schramm, M.D.F. Silva, E.K. Kano, E.E.M. Koono, V. Porta, and C.H.D.R. Serra, Int. J. Pharm., 366, 149 (2009)
  • [11] Y. Dotsikas, C. Kousoulos, G. Tsatsou, and Y.L. Loukas, J. Chromatogr. B, 836, 79 (2006)
  • [12] K. Liu, X. Dai, D. Zhong, and X. Chen, J. Chromatogr. B, 864, 129 (2008)
  • [13] X. Xu, M.G. Barlett, and J.T. Stewart, J. Mass Spectrom., 35, 1329 (2000)
  • [14] USFDA, Guidance for Industry: Bioavailability and bioequivalence studies for orally administered drug products — General considerations. US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Rockville, MD, March 2003
  • [15] Note for Guidance: Investigation of Bioavailability and Bioequivalence. Committee for Proprietary Medicinal Products (CPMP), London, UK, December 2000
  • [16] R.L. Nation and L.N. Sansom, Pharmacol. Therapeut., 62, 41 (1994)
  • [17] J.G. Wagner, Statistics: Fundamentals of Clinical Pharmacokinetics, Drug Intelligence Publications, Hamilton, 1975, 285
  • [18] USFDA, Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Rockville, MD, May 2001
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-68eb01a4-4311-4186-ab3c-c78f282d0145
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