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  • Development of simplified HPLC methods for the detection of counterfeit antimalarials in resource-restraint environments.

Development of simplified HPLC methods for the detection of counterfeit antimalarials in resource-restraint environments.

Journal of pharmaceutical and biomedical analysis (2014-07-13)
Ludwig Hoellein, Ulrike Holzgrabe
ABSTRACT

Regular quality control and post-marketing surveillance of pharmaceuticals has been a critical challenge for countries of the developing world ever since. Counterfeit and substandard medicines are widely distributed and the real extent of their prevalence still remains unknown. Compendial protocols and methods utilizing high-performance liquid chromatography (HPLC) which are described in the major pharmacopoeias are widely applied for the quality control of a compound. They often require expensive solvents, delicate reagents and/or sophisticated apparatus, and may not be applicable and affordable for laboratories with limited capabilities. Simple but robust HPLC methods for the determination of five commonly used antimalarial agents, i.e. amodiaquine, mefloquine, proguanil, artemether and lumefantrine, were developed and their suitability for routine use in resource-restraint environments is discussed. They solely require readily available chemicals and solvents and exhibit a high grade of ruggedness.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Acetonitrile, suitable for HPLC, gradient grade, ≥99.9%
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Acetonitrile, anhydrous, 99.8%
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Acetonitrile, ACS reagent, ≥99.5%
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Phosphoric acid, puriss. p.a., crystallized, ≥99.0% (T)
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Quinidine hydrochloride monohydrate, technical grade
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Phosphoric acid, crystalline, ≥99.999% trace metals basis
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Phosphoric acid, ACS reagent, ≥85 wt. % in H2O
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Ethyl acetate, ACS reagent, ≥99.5%
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Acetonitrile, suitable for HPLC, gradient grade, ≥99.9%
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Acetonitrile, HPLC Plus, ≥99.9%
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Ethyl acetate, HPLC Plus, for HPLC, GC, and residue analysis, 99.9%
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Phosphoric acid, ACS reagent, ≥85 wt. % in H2O
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Ethyl acetate
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Ethyl acetate
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Acetonitrile, suitable for DNA synthesis, ≥99.9% (GC)
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Acetonitrile, ≥99.8%, suitable for HPLC
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Ethyl acetate, suitable for HPLC, ≥99.7%
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Residual Solvent Class 2 - Acetonitrile, United States Pharmacopeia (USP) Reference Standard
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Acetonitrile, suitable for HPLC-GC, ≥99.8% (GC)
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