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A model procedure for the transfer of TLC pharmaceutical product screening methods designed for use in developing countries to quantitative HPTLC-densitometry methods

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Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
Transfer of four rapid thin-layer chromatography (TLC) screening methods used to detect substandard and counterfeit pharmaceutical products to quantitative high-performance TLC (HPTLC)-densitometry methods is demonstrated. These methods for acetaminophen, acetylsalicylic acid, ibuprofen, and chlorpheniramine maleate are contained in a Compendium of methods developed by Kenyon and Layloff for use in countries with limited resources. The new quantitative methods use Merck HPTLC silica gel 60 F254 glass plates, automated standard and sample application, and automated densitometry for detection, identification, and quantification. Standard and sample solution preparation and application procedures for obtaining calibration curves and bracketed samples are described. The HPTLC plates give better efficiency, selectivity, and resolution than TLC, and the new methods overcome the deficiencies in technology related to manual application and visual zone comparison that do not allow the Compendium TLC procedures to support regulatory compliance actions. These transferred methods can be fully validated according to International Conference on Harmonization (ICH) guidelines or by interlaboratory studies if their applications require. The approach described can be used to transfer the remaining Compendium methods as well as the GPHF [Global (formerly German) Pharma Health Fund E.V.] Minilab kit TLC screening methods.
Rocznik
Strony
241--252
Opis fizyczny
Bibliogr. 16 poz., rys., tab.
Twórcy
  • Lafayette College Department of Chemistry Easton PA 18042 USA
autor
  • Lafayette College Department of Chemistry Easton PA 18042 USA
Bibliografia
  • [1] J. Sherma, Acta Chromatogr., 19, 5–20 (2007)
  • [2] J. Sherma, Encyclopedia of Chromatography, 3rd edn, DOI: 10.1081/E-ECHR3-120044849
  • [3] http://www.gphf.org
  • [4] A.S. Kenyon and T.P. Layloff, A Compendium of Unofficial Methods for Rapid Screening of Pharmaceuticals by Thin Layer Chromatography, http://www.pharmweb.net/pwmirror/library/tlc/tlcall.pdf
  • [5] E. Kaale, P. Risha, E. Reich, and T.P. Layloff, J. AOAC Int., 93, 1836–1843 (2010)
  • [6] E. Reich and A. Schibli, J. Planar Chromatogr., 17, 438–443 (2004)
  • [7] T.H. Dzido and T. Tuzimski in: M. Waksmundzka-Hajnos, J. Sherma, and T. Kowalska (Eds) Thin Layer Chromatography in Phytochemistry, CRC Press/Taylor & Francis Group, Boca Raton, FL, 2008, p. 143
  • [8] A.S. Kenyon, T. Layloff, and J. Sherma, J. Liq. Chromatogr. Relat. Technol., 24, 1479–1490 (2001)
  • [9] E. Reich, CAMAG, Muttenz, Switzerland, Personal communication, August 12, 2010
  • [10] E. Hahn-Deinstrop, Applied Thin Layer Chromatography: Best Practice and Avoidance of Mistakes, Wiley-VCH, Weinheim, Germany, 2000, p. 48
  • [11] F. Rabel, ChromHELP, LLC, Woodbury, NJ, Personal communication, January 18, 2011
  • [12] B. Fried and J. Sherma, Thin Layer Chromatography, 4th edn, Marcel Dekker, New York, NY, 1999, pp. 89–107
  • [13] B. Hess and J. Sherma, Acta Chromatogr., 14, 60–69 (2004)
  • [14] E. Kaale, P. Risha, and T. Layloff, J. Chromatogr. A, doi:10.1016/j.chroma. 2010.12.022
  • [15] K. Ferenczi-Fodor, Z. Végh, A. Nagy-Turák, B. Renger, and M. Zeller, J. AOAC Int., 84, 1265–1276 (2001)
  • [16] K. Ferenczi-Fodor, B. Renger, and Z. Végh, J. Planar Chromatogr., 23, 173–179 (2010)
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-69b2b311-18c1-437f-b278-242a8714c0ff
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