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

Czasopismo : Acta Chromatographica
Tytuł artykułu : A model procedure for the transfer of TLC pharmaceutical product screening methods designed for use in developing countries to quantitative HPTLC-densitometry methods

Autorzy :
Sajewicz, M.
University of Silesia Department of General Chemistry and Chromatography 9 Szkolna Street 40-006 Katowice Poland,
Kowalska, T.
University of Silesia Department of General Chemistry and Chromatography 9 Szkolna Street 40-006 Katowice Poland, teresa.kowalska@us.edu.pl,
Szalka, M.
ICN Polfa Rzeszów S.A. Product Development Department 35-959 Rzeszów Poland,
Kostka, J.
Rzeszów University of Technology Department of Chemical and Process Engineering 35-959 Rzeszów,
Rokaszewski, E.
ICN Polfa Rzeszów S.A. Product Development Department 35-959 Rzeszów Poland,
Kaczmarski, K.
Rzeszów University of Technology Department of Chemical and Process Engineering 35-959 Rzeszów, kkaczmarski@prz.edu.pl,
Belal, F.
University of Mansoura Department of Analytical Chemistry, Faculty of Pharmacy 35516 Mansoura Egypt,
El-Brashy, A. M.
University of Mansoura Department of Analytical Chemistry, Faculty of Pharmacy 35516 Mansoura Egypt,
El-Enany, N.
University of Mansoura Department of Analytical Chemistry, Faculty of Pharmacy 35516 Mansoura Egypt,
Tolba, M. M.
University of Mansoura Department of Analytical Chemistry, Faculty of Pharmacy 35516 Mansoura Egypt,
Cielecka-Piontek, J.
Poznan University of Medical Sciences Department of Pharmaceutical Chemistry, Faculty of Pharmacy Grunwaldzka 6 60-780 Poznań Poland, jpiontek@ump.edu.pl,
Krause, A.
PozLab Contract Research Organization Poznań Poland,
Zalewski, P.
Poznan University of Medical Sciences Department of Pharmaceutical Chemistry, Faculty of Pharmacy Grunwaldzka 6 60-780 Poznań Poland,
Lunzer, A.
Tanaka Laboratory in Hokkaido University W 7, Kita-ku Sapporo 060-8638 Japan,
Jelińska, A.
Poznan University of Medical Sciences Department of Pharmaceutical Chemistry, Faculty of Pharmacy Grunwaldzka 6 60-780 Poznań Poland,
Sarju, N.
Universiti Teknologi Malaysia Department of Industrial Biotechnology, Faculty of Biosciences and Bioengineering 81310 Skudai, Johor Bahru, Johor Malaysia,
Abd Samad, A.
Universiti Teknologi Malaysia Department of Industrial Biotechnology, Faculty of Biosciences and Bioengineering 81310 Skudai, Johor Bahru, Johor Malaysia,
Abd Ghani, M.
Universiti Kebangsaan Malaysia School of Chemical Sciences and Food Technology 43600 UKM Bangi, Selangor Malaysia,
Ahmad, F.
Universiti Teknologi Malaysia Department of Chemistry, Faculty of Science 81310 Skudai, Johor Bahru, Johor Malaysia, farediah@kimia.fs.utm.my,
Yang, G. J.
China Pharmaceutical University School of Pharmacy Nanjing 210009 P. R. China, yanggongjun888@163.com,
Lv, L.
Yangzhou University College of Chemistry and Chemical Engineering Yangzhou 225002 P. R. China,
O’sullivan, C.
Lafayette College Department of Chemistry Easton PA 18042 USA,
Sherma, J.
Lafayette College Department of Chemistry Easton PA 18042 USA, shermaj@lafayette.edu,
Abstrakty : 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 : high performance thin layer chromatography, HPTLC, densitometry, pharmaceutical product screening, drug analysis, counterfeit drugs, transfer of TLC methods to HPTLC-densitometry,
Wydawnictwo : University of Silesia in Katowice
Rocznik : 2012
Numer : Vol. 24, no. 2
Strony : 241 – 252
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)
DOI :
Cytuj : Sajewicz, M. ,Kowalska, T. ,Szalka, M. ,Kostka, J. ,Rokaszewski, E. ,Kaczmarski, K. ,Belal, F. ,El-Brashy, A. M. ,El-Enany, N. ,Tolba, M. M. ,Cielecka-Piontek, J. ,Krause, A. ,Zalewski, P. ,Lunzer, A. ,Jelińska, A. ,Sarju, N. ,Abd Samad, A. ,Abd Ghani, M. ,Ahmad, F. ,Yang, G. J. ,Lv, L. ,O’sullivan, C. ,Sherma, J. , A model procedure for the transfer of TLC pharmaceutical product screening methods designed for use in developing countries to quantitative HPTLC-densitometry methods. Acta Chromatographica Vol. 24, no. 2/2012
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