Journal : Acta Chromatographica
Article : Transfer of TLC screening methods designed for use in developing countries to quantitative HPTLC-densitometry methods for diazepam and amodiaquine tablets

Authors :
Kuc, J.
Cracow University of Technology Department of Chemical Engineering and Technology, Department of Analytical Chemistry Warszawska 24 31-155 Cracow Poland, jkuc@chemia.pk.edu.pl,
Grochowalski, A.
Cracow University of Technology Department of Chemical Engineering and Technology, Department of Analytical Chemistry Warszawska 24 31-155 Cracow Poland,
Mach, S.
Institute of Public Health Ostrava Centre of Hygienic Laboratories Dobrá 240 739 51 Frýdek-Místek Czech Republic,
Placha, D.
VŠB-Technical University of Ostrava Centrum Nanotechnology 17 Listopadu 15/2172 708 33 Ostrava Czech Republic,
Furusawa, N.
Osaka City University Graduate School of Human Life Science Osaka 558-8585 Japan,
Stoilova, N.
Bulgarian Food Safety Agency Central Laboratory of Veterinary Control and Ecology (CLVCE) 5 “Iskarsko shousse” str., 1528 Sofia Bulgaria, nadqstoilova@abv.bg,
Surleva, A.
University of Chemical Technology and Metallurgy Analytical Chemistry Department 8 “St. Kl. Ohridski” blvd., 1756 Sofia Bulgaria,
Stoev, G.
Bulgarian Food Safety Agency Central Laboratory of Veterinary Control and Ecology (CLVCE) 5 “Iskarsko shousse” str., 1528 Sofia Bulgaria,
Popovic, N.
Lafayette College Department of Chemistry Easton PA USA,
Sherma, J.
Lafayette College Department of Chemistry Easton PA USA, shermaj@lafayette.edu,
Abstract : Transfer of two rapid thin-layer chromatography (TLC) screening methods used to detect markedly substandard and fake pharmaceutical products to quantitative high-performance TLC (HPTLC)-densitometry methods is demonstrated using a model procedure that was published earlier. These TLC methods for diazepam and amodiaquine are contained in a Compendium of methods by Kenyon and Layloff and a Minilab method manual from Global Pharma Health Fund E.V., respectively, for use in countries with limited resources. Merck HPTLC Premium Purity silica gel 60 F254 glass plates, automated standard and sample solution application with a CAMAG Linomat 4, and automated densitometry with a CAMAG Scanner 3 were used for detection, identification, and quantification. Sample peak identity and purity validation were carried out by spectral comparison checks available in the winCATS software. Accuracy was estimated by the standard addition approach with overspotting standard and sample solutions. HPTLC gives 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 and Minilab TLC procedures to support regulatory compliance actions. These new methods can be fully validated according to the International Conference on Harmonization guidelines or by interlaboratory studies if required by their applications.

Keywords : diazepam, amodiaquine, thin-layer chromatography, densitometry, pharmaceutical product screening, drug analysis, fake drugs, transfer of TLC methods to HPTLC-densitometry,
Publishing house : University of Silesia in Katowice
Publication date : 2014
Number : Vol. 26, no. 4
Page : 615 – 623

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DOI :
Qute : Kuc, J. ,Grochowalski, A. ,Mach, S. ,Placha, D. ,Furusawa, N. ,Stoilova, N. ,Surleva, A. ,Stoev, G. ,Popovic, N. ,Sherma, J. ,Sherma, J. , Transfer of TLC screening methods designed for use in developing countries to quantitative HPTLC-densitometry methods for diazepam and amodiaquine tablets. Acta Chromatographica Vol. 26, no. 4/2014
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