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

• Autorzy: Strock J. , Nguyen M. , Sherma J.
• Języki publikacji: EN

Abstrakty

EN

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.

Słowa kluczowe

EN

quinine sulfate; mefloquine; dihydroartemisinin; piperaquine; lumefantrine; artemether; thin-layer chromatography; fake drugs; transfer of TLC methods to HPTLC—densitometry

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2016
• Tom: Vol. 28, no. 3
• Strony: 363--372
• Opis fizyczny: Bibliogr. 10 poz., rys., tab.

Twórcy

autor

Strock J.

• Department of Chemistry, Lafayette College, Easton, Pennsylvania, USA

autor

Nguyen M.

• Department of Chemistry, Lafayette College, Easton, Pennsylvania, USA

autor

Sherma J.

Bibliografia

• [1] J. Sherma and C. O’Sullivan, Acta Chromatogr., 24, 241–252 (2012)
• [2] K. Lianza and J. Sherma, J. Liq. Chromatogr. Relat. Technol., 36, 2446–2452 (2013)
• [3] N. Popovic and J. Sherma, Acta Chromatogr., 26, 615–623 (2014)
• [4] M. Nguyen and J. Sherma, Trends Chromatogr., 8, 131–135 (2013)
• [5] M. Nguyen and J. Sherma, J. Liq. Chromatogr. Relat. Technol., 37, 2956–2970 (2014)
• [6] J. Strock, M. Nguyen, and J. Sherma, J. Liq. Chromatogr. Relat. Technol., in press
• [7] K. Ferenczi-Fodor, Z. Vegh, A. Nagy-Turak, B. Renger, and M. Zeller, J. AOAC Int., 84, 1265–1276
• [8] A. S. Kenyon and T. P. Layloff, http://www.pharmweb.net/pwmirror/library/tlc/tlcall. pdf
• [9] http://www.gphf.org
• [10] E. Kaale, P. Risha, E. Reich, and T. P. Layloff, J. AOAC Int., 93, 1836–1843 (2010)

Uwagi

PL

Opracowanie ze środków MNiSW w ramach umowy 812/P-DUN/2016 na działalność upowszechniającą naukę.