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Use of validated stability-indicating chromatographic methods for quantitative analysis of idrocilamide in a pharmaceutical formulation

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
Two sensitive and selective chromatographic methods have been developed and validated for analysis of idrocilamide in the presence of its degradation products. Forced degradation studies were performed using HCl, NaOH, and 3% H2O2. The first method is based on thin-layer chromatographic separation of the intact drug from its degradation products, followed by densitometric measurement. The second method is based on isocratic reversed phase high-performance liquid chromatographic separation of the drug from its degradation products on a C18 column. The HPLC method was used to investigate the kinetics of alkaline degradation of the drug at different temperatures.
Słowa kluczowe
Rocznik
Strony
569--579
Opis fizyczny
Bibliogr. 12 poz., rys., tab.
Twórcy
autor
  • Cairo University Analytical Chemistry Department, Faculty of Pharmacy Cairo Egypt
  • National Organization for Drug Control and Research (NODCAR) 6 Abu Hazem Street, Pyramids P.O. Box 29 Cairo Egypt
  • National Organization for Drug Control and Research (NODCAR) 6 Abu Hazem Street, Pyramids P.O. Box 29 Cairo Egypt
  • Cairo University Analytical Chemistry Department, Faculty of Pharmacy Cairo Egypt
Bibliografia
  • [1] The Merck Index, 14th edn., Merck and Co. Inc., Whitehouse Station NJ, USA, 2006, pp. 849
  • [2] Martindale: The complete drug reference, 35 th edn. Pharmaceutical Press, London, Sweetman SC, 2007, pp. 931–932
  • [3] B. Bannwarth, J.C. Le Huec, G. Vinçon, L. Labat, F. Demotes-Mainard, F. Rivaille, and A. Le Rebeller, Rev. Rhum. Ed. Fr., 60 , 932–936 (1993)
  • [4] M. Stehman and P. Lehert, Acta Belg. Med. Phys., 13 , 29–32 (1990)
  • [5] P. Panse, P. Zeiller, K.H. Sensch, Arzneimittelforschung, 24 , 1298–1301 (1974)
  • [6] Y.J.F. Xu, G. Yang, W.J. Zhao, Zhongguo Yaoxue Zazhi, 28 , 224–226 (1993)
  • [7] J. Xu, J. Wang, S. Zeng, X. Zheng, Zhongguo Yiyao Gongye Zazhi, 20 , 467–469 (1990)
  • [8] ICH Q2A, Validation of analytical methods: definitions and terminology, In IFPMA (ed), International Conference on Harmonization, Geneva, 1994
  • [9] ICH Q2B Validation of analytical procedure: methodology, In IFPMA (ed), International Conferences on Harmonization, Geneva, 1996
  • [10] Clark’s “Analysis of Drugs and Poisons in Pharmaceuticals”, Body Fluids and Postmortem Material, third edition, Pharmaceutical Press, London, 2004, p. 293
  • [11] British Pharmacopoeia, Her Majesty’s Stationary Office, London, UK, 2008, pp. 563–565
  • [12] The United States Pharmacopoeia, “The National Formulary” USP 30, United States Pharmacopeial Convention Inc., 2007, pp. 3050–3052
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-8c442bdb-543d-49e6-a2b7-9e7b9caebc4b
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