Use of a model process for transfer of minilab TLC screening methods for quinine sulfate, mefloquine, and dihydroartemisinin-piperaquine phosphate tablets to quantitative HPTLC-densitometry methods

Transfer of four thin-layer chromatography (TLC) Global Pharma Health Fund Minilab mobile kit protocols for detecting fake pharmaceutical products to quantitative high-performance TLC (HPTLC)—densitometry methods was carried out using a model process published earlier. The developed and validated methods were for the drugs quinine sulfate, mefloquine, dihydroartemisinin, and piperaquine phosphate. EMD Millipore 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 for detection, identification, and quantification were used. Sample peak identity and purity validation were carried out by spectral comparison checks available in the winCATS software, and accuracy was estimated by the standard addition approach. 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 Minilab TLC procedures to support regulatory compliance actions. These new methods should be fully validated according to International Conference on Harmonization guidelines or by interlaboratory studies if required by their applications. In addition, a previously reported transferred simultaneous HPTLC–densitometry method for lumefantrine and artemether was used to analyze a new combination tablet to demonstrate its applicability.

Title	Use of a model process for transfer of minilab TLC screening methods for quinine sulfate, mefloquine, and dihydroartemisinin-piperaquine phosphate tablets to quantitative HPTLC-densitometry methods
Creator	Nguyen, M.
	Sherma, Joseph
	Stock, J.
Publisher	Acta Chromatographica
Academic Department	Chemistry
Division	Natural Sciences
Organization	Lafayette College
Date Issued	September 2016
Date Available	2016-09-13T20:39:19Z
Type	Article
Language	English
Keyword	piperaquine
	quinine sulfate
	dihydroartemisinin
	lumefantrine
	artemether
	fake drugs
	mefloquine
	transfer of TLC methods to HPTLC– densitometry
	thin-layer chromatography
Bibliographic Citation	Stock, J., M. Nguyen, and J. Sherma (2016 Sept) "Use of a model process for transfer of minilab TLC screening methods for quinine sulfate, mefloquine, and dihydroartemisinin-piperaquine phosphate tablets to quantitative HPTLC-densitometry methods." Acta Chromatographica 28 (3): 363–72.
Standard Identifier	DOI 10.1556/1326.2016.28.3.6
Standard Identifier	Handle 10385/2136
Permalink	http://hdl.handle.net/10385/2136
Rights Statement	Creative Commons - Attribution
Rights Holders	Nguyen, M.
	Sherma, Joseph
	Stock, J.