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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

Primaquine diphosphate, European Pharmacopoeia (EP) Reference Standard
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Ammonia, anhydrous, ≥99.98%
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Methanol, NMR reference standard
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Sodium hydroxide, SAJ first grade, ≥95.0%
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Ammonia solution, 0.4 M in THF
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Methanol, SAJ special grade
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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 3 mm × 8 in.
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Methanol, HPLC Plus, ≥99.9%, poly-coated bottles
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Residual Solvent - Acetonitrile(solution in DMSO), Pharmaceutical Secondary Standard; Certified Reference Material
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Ammonia-14N, 99.99 atom % 14N
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Sodium hydroxide solution, BioUltra, for molecular biology, 10 M in H2O
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Methanol, anhydrous, 99.8%
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Tetraheptylammonium bromide, suitable for ion pair chromatography, LiChropur, ≥99.0% (AT)
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3-Ethyl-2,4-pentanedione, mixture of tautomers, 98%
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Methanol, suitable for HPLC, gradient grade, 99.93%
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Phosphoric acid solution, 85 wt. % in H2O, FCC, FG
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Sodium sulfate, JIS special grade, ≥99.0%
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Sodium hydroxide, JIS special grade, ≥96.0%
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Methanol, JIS 300, ≥99.8%, for residue analysis
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Methanol, JIS special grade, ≥99.8%
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Methanol, SAJ first grade, ≥99.5%
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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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Acetonitrile solution, contains 0.05 % (v/v) trifluoroacetic acid
USP
Primaquine phosphate, United States Pharmacopeia (USP) Reference Standard
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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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Sodium sulfate, anhydrous, free-flowing, Redi-Dri, ACS reagent, ≥99%
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Sodium hydroxide, beads, 16-60 mesh, reagent grade, 97%
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Ammonia solution, 2.0 M in methanol
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Methanol, puriss., meets analytical specification of Ph Eur, ≥99.7% (GC)