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Tytuł artykułu

Simultaneous RP-IP-HPLC assay of theophylline, phenobarbital, codeine, and ephedrine in a suppository

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
A reversed-phase ion-pairing liquid chromatographic (RP-IP-HPLC) method for simultaneous assay of theophylline (TH), phenobarbital (PB), codeine (CD), and ephedrine (EP) in an extemporaneous (magistral) suppository was developed and validated and used to investigate a reported serious adverse event. Samples were dissolved in dichloromethane and extracted by two-step liquid-liquid extraction with acetate buffer (pH 5.0) and, subsequently, 0.1 M NaOH solution. Separation was performed on an end-capped C 18 silica column with stepwise gradient elution. Sample preparation and chromatographic conditions were optimized on the basis of the p K a values of the analytes. Freedom from interference from the excipients, linearity ( r 2 > 0.999 for all the active ingredients), range (0.01–0.08 mg mL -1 for TH, CD, and EP; 0.0025–0.02 mg mL -1 for PB), intra-day and inter-day precision, and accuracy (recovery >95% for TH, CD, and EP and >90% for PB) of the method were demonstrated. Non-compliance of the examined product was confirmed.
Słowa kluczowe
Rocznik
Strony
527--538
Opis fizyczny
Bibliogr. 24 poz., rys., tab.
Twórcy
autor
  • National Institute of Pharmacy PO Box 450 1051 Budapest Hungary
autor
  • National Institute of Pharmacy PO Box 450 1051 Budapest Hungary
  • National Institute of Pharmacy PO Box 450 1051 Budapest Hungary
  • National Institute of Pharmacy PO Box 450 1051 Budapest Hungary
Bibliografia
  • [1] Formulae Normales VII, Országos Gyógyszerészeti Intézet, Budapest, Hungary, 2003
  • [2] Deutscher Arzneimittel Codex — Neues Rezeptur-Formularium, Govi Verlag, Eschborn, Germany, 2008
  • [3] Formularium der Nederlandse Apothekers, Koninklijke Nederlandse Maatschappij ter Bevordering der Pharmacie, Den Haag, The Netherlands, 2004
  • [4] Pharmacopoea Helvetica 10, Swissmedic, Schweitzerisches Heilmittelinstitut, Bern, Switzerland, 2006
  • [5] British Pharmacopoeia, The Stationery Office, London, United Kingdom, 2008
  • [6] Formulaire National Complement À La Pharmacopée Française (1974), Agence Française de Sécurité Sanitaire des Produits de Santé, Saint-Denis, France
  • [7] United States Pharmacopeia, 32 — National Formulary 27, The United States Pharmacopeia Convention, Rockville, MD, 2009, pp. 3711–3712
  • [8] Standards for Quality of Pharmaceutical Services — Good Pharmacy Practice, International Pharmaceutical Federation, The Hague, The Netherlands, 1997
  • [9] A. Haque, X. Xu, and J. T. Stewart, J. Pharm. Biomed. Anal., 21 , 1063–1067 (1999)
  • [10] O.W. Lau, K. Chan, Y.K. Lau, and W.C. Wong, J. Pharm. Biomed. Anal., 7 , 725–736 (1989)
  • [11] O.W. Lau and C.S. Mok, J. Chromatogr. A, 693 , 45–54 (1995)
  • [12] D.J. Hood and H.Y. Cheung, J. Pharm. Biomed. Anal., 30 , 1595–1601 (2003)
  • [13] M.R. Gomez, L. Sombra, R.A. Olsina, L.D. Martínez, and M.F. Silva, Farmaco, 60 , 85–90 (2005)
  • [14] G.B. Golubitskii and E.V. Budko, Pharm. Chem. J., 40(11 ), 633–637 (2006)
  • [15] Q. Dang, L. Yan, Z. Sun, and D. Ling, J. Chromatogr. A, 630 , 363–369 (1993)
  • [16] S.E. Roberts and M.F. Delaney, J. Chromatogr. A, 242 , 364–368 (1982)
  • [17] D. Boberić-Borojević, D. Radulović, D. Ivanović, and P. Ristić, J. Pharm. Biomed. Anal., 21 , 15–22 (1999)
  • [18] Z. Şentürk, N. Erk, S.A. Özkan, C. Akay, and Ş. Cevheroğlu, J. Pharm. Biomed. Anal., 29 , 291–298 (2002)
  • [19] ICH Harmonised Tripartite Guideline — Validation of Analytical Procedures: Text and Methodology Q2(R1), International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2005, pp. 1–13
  • [20] The European Pharmacopoeia, 6th Edition (2008); European Directorate for the Quality of Medicines & HealthCare (EDQM), Strasbourg, France, pp. 1596–1598
  • [21] L.R. Snyder and J.J. Kirkland, Introduction to Modern Liquid Chromatography (Second Edition), John Wiley and Sons, New York, 1979, p. 559
  • [22] G. Zweig and J. Sherma, Handbook of Chromatography, Volume II, CRC Press, Cleveland, 1972, p. 32
  • [23] B. Ravindranath, Principles and Practice of Chromatography, Ellis Horwood Ltd, Chichester, 1989, p. 199
  • [24] Hungarian Pharmacopoeia, 7th Edition (1986); National Institute of Pharmacy, Budapest, Hungary, p. 2087
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-08d81ad8-be1d-43f0-9100-c5f8be6caf22
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