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Identification and characterization of olanzapine degradation products under oxidative stress conditions

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
Studies of the degradation of olanzapine bulk drug under hydrolytic (acidic and alkaline), oxidising, and photolytic conditions are reported in this paper. Olanzapine is almost completely stable under photolytic and hydrolytic (acidic and alkaline) conditions. The major degradation products formed when olanzapine bulk drug was exposed to oxidative stress conditions were isolated by preparative reversed-phase highperformance liquid chromatography and characterized by FTIR, LC-MS-MS, and 1H, 13C, and DEPT NMR. On the basis of results from spectroscopy the degradation products were characterized as 10-hydroxy-2-methyl-5,10-dihydro-4H-benzo[b]thieno [2,3- e][1,4]diazepin-4-one, 2-methyl-5,10-dihydro-4H-benzo[b]thieno[2,3-e][1,4]diazepin-4- one, and 2-methyl-10-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4] diazepin-4-yloxy)-5,10- dihydro-4H-benzo[b]thieno[2,3-e]diazepin-4-one. Identification, isolation, and characterization of these oxidative degradation products are discussed in detail.
Słowa kluczowe
Rocznik
Strony
81--93
Opis fizyczny
Bibliogr. 11 poz., rys., tab.
Twórcy
autor
autor
autor
  • University of Mysore DOS in Chemistry Manasagangothri, Mysore 570006 India Peenya Industrial Area Process Chemistry Department, Advinus Therapeutics Bangalore 560058 India
Bibliografia
  • [1] International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Stability Testing of New Drug Substances and Products. QIA (R2), August, 2003
  • [2] International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Stability Testing: Photo Stability Testing of New Drug Substances and Products. QIB, January, 1998
  • [3] S. Singh and M. Bakshi, Pharmaceutical Technology on-line, April, 2000
  • [4] L.J. Dusei, L.P. Hackett, L.M. Fellows, and K.F. Ilett, J. Chromatogr. B, 774, 191 (2002)
  • [5] O.V. Olesen and K. Linnet, J. Chromatogr. B, 714, 309 (1998)
  • [6] J.A. Chiu and R.B. Franklin, J. Pharm. Biomed. Anal., 14, 609 (1996)
  • [7] J.T. Catlow, R.D. Barton, M. Clemens, T.A. Gillespie, M. Goodwin, and S.P.Swanson, J. Chromatogr. B, 668, 85 (1999)
  • [8] M.J. Bogusz, K.D. Kruger, R.D. Maier, R. Erkwoh, and F. Juchtenhagen, J. Chromatogr. B, 732, 257 (1999)
  • [9] L.A. Larew, B.A. Olsen, J.D. Stafford, and M.V. Wilhelm, J. Chromatogr. A, 692, 183 (1995)
  • [10] M.A. Raggi, G. Lasamenti, R. Mandroli, G. Izzo, and E. Kenndler, J. Pharm. Biomed. Anal. 23, 973 (2000)
  • [11] S.W. Baertschi, H. Brunner, C.A. Bunnell, G.G. Cooke, B. Diseroad, D.E. Dorman, P.J. Jansen, C.A.J. Kemp, S.R. Maple, K.A. McCune, J.L. Speakman, J. Pharm. Sci. 97(2) 883–892 (2007).
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-article-BATE-0001-0007
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