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Abstrakty
This paper reports development and validation of a new microemulsion liquid chromatographic (MELC) method for rapid screening of simvastatin and simvastatin acid in human plasma. Plasma samples were injected directly into the HPLC system after appropriate sample dilution with mobile phase. Separations were performed on a 4.6 mm × 150 mm, 5-µm particle, C 18 column, with UV detection at 238 nm. The mobile phase was 0.5% ( w/u ) diisopropyl ether, 1.0% ( w/u ) sodium dodecylsulphate (SDS), 4.0% ( w/v ) n -butanol, and 94.5% ( w/w ) aqueous 25 mM disodium hydrogen phosphate, pH 7.0, at a flow rate of 1 mL min -1 . The method was evaluated according to criteria stated in FDA bioanalytical method validation guidance. The unique approach applied in this paper enables direct analysis of simvastatin and simvastatin acid, so the method can be used to obtain reliable results in a rapid and simple way.
Czasopismo
Rocznik
Tom
Strony
595--607
Opis fizyczny
Bibliogr. 16 poz., rys., tab.
Twórcy
autor
autor
autor
autor
- Faculty of Pharmacy Department of Drug Analysis Vojvode Stepe 450 Belgrade Serbia Faculty of Pharmacy Department of Physical Chemistry Vojvode Stepe 450 Belgrade Serbia, andja@pharmacy.bg.ac.yu
Bibliografia
- [1] C. Dollery, Therapeutic Drugs, Churchill Livingstone, Edinburgh, 1999
- [2] J. De Graaf, P.N. Demacker, and A.F. Stalenhoef, Neth. J. Med., 43 , 254 (1993)
- [3] G. Carlucci, P. Mazzeo, L. Biordi, and M. Bologna, J. Pharm. Biomed. Anal., 10 , 693 (1992)
- [4] H. Ochiai, N. Uchiyama, K. Imagaki, S. Hata, and T. Kamei, J. Chromatogr. B, 694 , 211 (1997)
- [5] J.D. Gilbert, T.V. Olah, M.J. Morris, M.S. Schwartz, and D.A. McLoughlin in: E. Reid, H.M. Hill, and I.D. Wilson (Eds) Methodological Surveys in Bioanalysis of Drugs, Vol. 23, Royal Society of Chemistry, Cambridge, 1994
- [6] J. Shentu, X. Zhang, Z. Chen, L. Wu, and M. Shi, Yaowu Fenxi Zazhi (Chinese J. Pharm. Anal.), 22 , 18 (2002)
- [7] L. Tan, L. Yang, X. Zhang, Y. Yuan, and S. Ling, Sepu (Chinese J. Chromatogr.), 18 , 232 (2000)
- [8] B. Barret, J. Huclova, V. Borek-Dohalsky, B. Nemec, and I. Jelinek, J. Pharm. Biomed. Anal., 41 , 517 (2006)
- [9] H. Yang, Y. Feng, and Y. Luan, J. Chromatogr. B, 785 , 369 (2003)
- [10] X.S. Miao and C.D. Metcalfe, J. Chromatogr. A, 998 , 133 (2003)
- [11] M.J. Morris, J.D. Gilbert, J.Y.K. Hsieh, B.K. Matuszewski, H.G. Ramjit, and W.F. Bayne, Biol. Mass Spectrom., 22 , 1 (1993)
- [12] D.T.M. El-Sherbiny, S.M. El-Ashry, M.A. Mustafa, A. Abd-El-Rahman El-Emam, and S.H. Hansen, J. Sep. Sci., 26 , 503 (2003)
- [13] B. Jančić, D. Ivanović, M. Medenica, A. Malenović, and N. Dimković, J. Chromatogr. A, 1088 , 187 (2005)
- [14] Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human Service, Food and Drug Administration, CDER, Rockville, USA, May 2001
- [15] P.J. Pentikainen, M. Saraheimo, J.I. Schwartz, R.D. Amin, M.S. Schwartz, F.D. Brunner-Ferber, and J.D. Rogers, J. Clin. Pharmacol., 32 , 136 (1992)
- [16] P.H. Hubert, P. Chiep, J. Crommen, B. Boulanger, E. Chapizet, N. Mercier, S. Bervoas-Martin, P. Chevalier, D. Grandjean, P. Lagorce, M. Lallier, M.C. Laparra, M. Laurentie, and J.C. Nivet, Anal. Chim Acta, 391 , 135 (1999).
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-article-BATE-0001-0045