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

• Autorzy: O’sullivan C , Sherma J.
• 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.

Słowa kluczowe

EN

high performance thin layer chromatography; HPTLC; densitometry; pharmaceutical product screening; drug analysis; counterfeit drugs; transfer of TLC methods to HPTLC-densitometry

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2012
• Tom: Vol. 24, no. 2
• Strony: 241--252
• Opis fizyczny: Bibliogr. 16 poz., rys., tab.

Twórcy

autor

O’sullivan C

• Lafayette College Department of Chemistry Easton PA 18042 USA

autor

Sherma J.

• Lafayette College Department of Chemistry Easton PA 18042 USA

Bibliografia

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• [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
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• [9] E. Reich, CAMAG, Muttenz, Switzerland, Personal communication, August 12, 2010
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• [11] F. Rabel, ChromHELP, LLC, Woodbury, NJ, Personal communication, January 18, 2011
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