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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 0.05 % (v/v) trifluoroacetic acid
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Ammonia-14N, 99.99 atom % 14N
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Acetonitrile solution, contains 0.1 % (v/v) formic acid, suitable for HPLC
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Tetraheptylammonium bromide, suitable for ion pair chromatography, LiChropur, ≥99.0% (AT)
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Tetraheptylammonium bromide, ≥99.0% (AT)
Sigma-Aldrich
Ammonia, anhydrous, ≥99.98%
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Phosphoric acid solution, 85 wt. % in H2O, FCC, FG
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Sodium sulfate, ≥99.0%, suitable for plant cell culture
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Residual Solvent - Acetonitrile(solution in DMSO), Pharmaceutical Secondary Standard; Certified Reference Material
Primaquine diphosphate, European Pharmacopoeia (EP) Reference Standard
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Sodium hydroxide, BioUltra, for luminescence, ≥98.0% (T), pellets
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Sodium hydroxide solution, 5.0 M
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Sodium hydroxide solution, BioUltra, for molecular biology, 10 M in H2O
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Methanol, NMR reference standard
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Phosphoric acid solution, NMR reference standard, 85% in D2O (99.9 atom % D), NMR tube size 5 mm × 8 in.
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Phosphoric acid solution, NMR reference standard, 85% in D2O (99.9 atom % D), NMR tube size 4.2 mm × 8 in. , WGS-5BL Coaxial NMR tube
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Methanol, JIS 300, ≥99.8%, for residue analysis
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Phosphoric acid solution, NMR reference standard, 85% in D2O (99.9 atom % D), NMR tube size 3 mm × 8 in.
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Sodium hydroxide, puriss. p.a., ACS reagent, K ≤0.02%, ≥98.0% (T), pellets
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Primaquine bisphosphate, 98%
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Methanol, ACS reagent, ≥99.8%
Supelco
Methanol, Pharmaceutical Secondary Standard; Certified Reference Material
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Methanol, ACS reagent, ≥99.8%
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Methanol, ACS spectrophotometric grade, ≥99.9%
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Chloroquine diphosphate salt, powder or crystals, 98.5-101.0% (EP)
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Ammonia solution, 0.4 M in dioxane
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Ammonia solution, 2.0 M in ethanol
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Ammonia solution, 4 M in methanol
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Acetonitrile(Neat), Pharmaceutical Secondary Standard; Certified Reference Material
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Sodium sulfate, tested according to Ph. Eur., anhydrous