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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 solution, contains 10.0% acetone, 0.05% formic acid, 40.0% 2-propanol
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Acetonitrile solution, contains 0.05 % (w/v) ammonium formate, 5 % (v/v) water, 0.1 % (v/v) formic acid, suitable for HPLC
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Acetonitrile solution, contains 0.1 % (v/v) formic acid, suitable for HPLC
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Acetonitrile solution, contains 0.05 % (v/v) trifluoroacetic acid
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Acetonitrile solution, contains 0.1 % (v/v) trifluoroacetic acid, suitable for HPLC
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Phosphoric acid solution, 85 wt. % in H2O, FCC, FG
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Primaquine bisphosphate, 98%
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Ammonia solution, 0.4 M in THF
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Ammonia, anhydrous, ≥99.98%
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Chloroquine diphosphate salt, powder or crystals, 98.5-101.0% (EP)
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Ammonia, puriss., anhydrous, ≥99.95%
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Tetraheptylammonium bromide, ≥99.0% (AT)
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Sodium sulfate, BioUltra, anhydrous, ≥99.0% (T)
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Methanol, analytical standard
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Methanol, anhydrous, 99.8%
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3-Ethyl-2,4-pentanedione, mixture of tautomers, 98%
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Tetraheptylammonium bromide, suitable for ion pair chromatography, LiChropur, ≥99.0% (AT)
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Ammonia-14N, 99.99 atom % 14N
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Methanol, Laboratory Reagent, ≥99.6%
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Sodium hydroxide, reagent grade, 97%, powder
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Sodium sulfate, puriss., meets analytical specification of Ph. Eur., BP, USP, anhydrous, 99.0-100.5% (calc. to the dried substance)
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Ammonia solution, 2.0 M in methanol
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Ammonia solution, 0.4 M in dioxane
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Sodium sulfate, ACS reagent, ≥99.0%, anhydrous, powder
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Sodium hydroxide, reagent grade, 97%, flakes
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Ammonia solution, 2.0 M in ethanol
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Sodium hydroxide solution, 50% in H2O
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Ammonia solution, 2.0 M in isopropanol
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