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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

Supelco
Sodium hydroxide concentrate, 0.1 M NaOH in water (0.1N), Eluent concentrate for IC
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Sodium sulfate, JIS special grade, ≥99.0%
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Sodium hydroxide solution, 7 M
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Sodium hydroxide solution, 6 M
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Methanol, JIS 300, ≥99.8%, for residue analysis
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Sodium hydroxide solution, 0.1 M
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Sodium hydroxide solution, 1 M
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Methanol, SAJ first grade, ≥99.5%
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Sodium hydroxide, JIS special grade, ≥96.0%
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Methanol, JIS special grade, ≥99.8%
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Sodium hydroxide solution, 4 M
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Methanol, SAJ special grade
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Methanol, suitable for HPLC
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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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Methanol, NMR reference standard
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Ammonia-14N, 99.99 atom % 14N
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Methanol, HPLC Plus, ≥99.9%, poly-coated bottles
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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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Phosphoric acid solution, NMR reference standard, 85% in D2O (99.9 atom % D), NMR tube size 5 mm × 8 in.
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Sodium sulfate, tested according to Ph. Eur., anhydrous
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Methanol, analytical standard
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Sodium sulfate, BioUltra, anhydrous, ≥99.0% (T)
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Sodium hydroxide solution, BioUltra, for molecular biology, 10 M in H2O
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Sodium hydroxide solution, 49-51% in water, eluent for IC
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Tetraheptylammonium bromide, ≥99.0% (AT)
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Sodium hydroxide, BioUltra, for luminescence, ≥98.0% (T), pellets
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Sodium sulfate, ≥99.99% trace metals basis
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Phosphoric acid solution, 85 wt. % in H2O, FCC, FG
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Methanol, suitable for HPLC, gradient grade, 99.93%
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3-Ethyl-2,4-pentanedione, mixture of tautomers, 98%