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Issue 5, 2012
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Characterization and identification of suspected counterfeit miltefosine capsules

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Abstract

Recently, it was revealed that generic miltefosine capsules for the treatment of visceral leishmaniasis, a fatal parasitic disease, were possibly counterfeit products. Here we report on the methods to characterize and identify miltefosine in pharmaceutical products and the procedures that were used to assess the quality of these suspected counterfeit products. Characterization and identification of miltefosine were done with liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS), Fourier transform infrared (FT-IR) spectroscopy and near-infrared (NIR) spectroscopy. Moreover, a simple, rapid and inexpensive colorimetric test was developed and evaluated for the detection of miltefosine in pharmaceutical products that can be used in the field. The complementary analytical techniques presented here were able to determine qualitatively or (semi-)quantitatively the presence or absence of miltefosine in pharmaceutical preparations and could identify suspected counterfeit miltefosine capsules. This finding of a suspected counterfeit drug intended to treat a neglected disease in a resource-poor country emphasizes the urgent need to develop more simple inexpensive assays to evaluate drug quality for use in the field.

Graphical abstract: Characterization and identification of suspected counterfeit miltefosine capsules

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Publication details

The article was received on 25 Jul 2011, accepted on 09 Dec 2011 and first published on 18 Jan 2012


Article type: Paper
DOI: 10.1039/C2AN15641E
Citation: Analyst, 2012,137, 1265-1274
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    Characterization and identification of suspected counterfeit miltefosine capsules

    T. P. C. Dorlo, T. A. Eggelte, P. J. de Vries and J. H. Beijnen, Analyst, 2012, 137, 1265
    DOI: 10.1039/C2AN15641E

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