Forced degradation study and validated stability-indicating RP-LC method for determination of nilotinib in bulk and capsules

• Autorzy: Fouad M. A. , Elkady E. F.
• Języki publikacji: EN

Abstrakty

EN

A simple, selective, and precise stability-indicating reversed-phase liquid chromatographic method was developed and validated for the determination of nilotinib. Nilotinib was subjected to acid and alkali hydrolysis, oxidation, thermal, and photo-degradation. The degradation products were well separated from the pure drug. The method was based on isocratic elution of nilotinib and its degradation products on reversed phase C18 column (100 mm × 4.6 mm, 3.5 μm) — Zorbax Eclipse Plus using a mobile phase consisting of 10 mM KH2PO4:acetonitrile (54.5:45.5%, v/v) at a flow rate of 1 mL min−1. Quantitation was achieved with UV detection at 265 nm. Linearity, accuracy and precision were found to be acceptable over the concentration range of 0.1–80 μg mL−1. The drug was found to be susceptible to acid and base hydrolysis but resistant to oxidation, dry heat degradation, and photodegradation. The proposed method was successfully applied to the determination of nilotinib in bulk and in its pharmaceutical preparation.

Słowa kluczowe

EN

nilotinib; reversed-phase liquid chromatography; stability-indicating assay; capsules; anticancer drugs

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2014
• Tom: Vol. 26, no. 4
• Strony: 637--647
• Opis fizyczny: Bibliogr. 14 poz., rys., tab.

Twórcy

autor

Fouad M. A.

• Cairo University Pharmaceutical Chemistry Department, Faculty of Pharmacy Kasr El-Aini St. Cairo 11562 Egypt

autor

Elkady E. F.

• Cairo University Pharmaceutical Chemistry Department, Faculty of Pharmacy Kasr El-Aini St. Cairo 11562 Egypt

Bibliografia

• [1] H. Kantarjian, F. Giles, L. Wunderle, K. Bhalla, S. O’Brien, B. Wassmann, et al., New Engl. J. Med., 354, 2542–2551 (2006)
• [2] D.L. Deremer, C. Ustun, and K. Natarajan, Clin. Therapeut., 30, 1956–1975 (2008)
• [3] R.A. Larson, B.J. Druker, F. Guilhot, S.G. O’Brien, G.J. Riviere, T. Krahnke, et al., Blood, 111, 4022–4028 (2008)
• [4] S. Picard, K. Titier, G. Etienne, E. Teilhet, D. Ducint, M.A. Bernard, et al., Blood, 109, 3496–3499 (2007)
• [5] M. Yuki, Y. Yamakawa, T. Uchida, T. Nambu, T. Kawaguchi, A. Hamada, et al., Biol. Pharm. Bull., 34, 1126–1128 (2011)
• [6] M. Miura, N. Takahashi, and K. Sawada, Biomed Chromatogr., 24, 789–793 (2010)
• [7] S. Pursche, O.G. Ottmann, G. Ehninger, and E. Schleyer, J. Chromatogr., B: Analytical Technol. Biomed. Life Sci., 852, 208–216 (2007)
• [8] A. Davies, A.K. Hayes, K. Knight, S.J. Watmough, M. Pirmohamed, and R.E. Clark, Leukemia Res., 34, 702–707 (2010)
• [9] G. Guetens, H. Prenen, G. De Boeck, A. van Oosterom, P. Schoeffski, M. Highley, et al., J. Chromatogr., B: Anal. Technol. Biomed. Life Sci., 846, 341–345 (2007)
• [10] R.A. Parise, M.J. Egorin, S.M. Christner, D.D. Shah, W. Zhou, and J.H. Beumer, J. Chromatogr., B: Anal. Technol. Biomed. Life Sci., 877, 1894–1900 (2009)
• [11] A. D’Avolio, M. Simiele, S. De Francia, A. Ariaudo, L. Baietto, J. Cusato, et al., J. Pharmaceut. Biomed. Anal., 59, 109–116 (2012)
• [12] S. De Francia, A. D’Avolio, F. De Martino, E. Pirro, L. Baietto, M. Siccardi, et al., J. Chromatogr., B: Anal. Technol. Biomed. Life Sci., 877, 1721–1726 (2009)
• [13] Q2 (R1) Validation of Analytical Procedures, Proceedings of the International Conference on Harmonisation (ICH), Commission of the European Communities, Geneva, 1996
• [14] The United States Pharmacopeia (USP 30), National Formulary (NF 25). Rockville, MD, 2007