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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
Phosphoric acid, BioReagent, suitable for insect cell culture, 85%
Sigma-Aldrich
Phosphoric acid, BioUltra, ≥85% (T)
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Phosphoric acid, crystalline, ≥99.999% trace metals basis
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Phosphoric acid, ACS reagent, ≥85 wt. % in H2O
Sigma-Aldrich
Phosphoric acid, puriss. p.a., crystallized, ≥99.0% (T)
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Phosphoric acid, puriss., meets analytical specification of Ph. Eur., BP, NF, FCC, 85.0-88.0%
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Phosphoric acid, ACS reagent, ≥85 wt. % in H2O
USP
Methyl alcohol, United States Pharmacopeia (USP) Reference Standard
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Phosphoric acid, ≥85 wt. % in H2O, ≥99.999% trace metals basis
Supelco
Acetonitrile, analytical standard
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Sodium hydroxide solution, 1.0 N, BioReagent, suitable for cell culture
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Quinidine hydrochloride monohydrate, technical grade
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Phosphoric acid, 85 wt. % in H2O, 99.99% trace metals basis
Supelco
Sodium hydroxide concentrate, 0.1 M NaOH in water (0.1N), Eluent concentrate for IC
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Sodium hydroxide solution, 49-51% in water, eluent for IC
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Ethyl acetate, natural, ≥99%, FCC, FG
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Ethyl acetate, ≥99%, FCC, FG
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Ethyl acetate, ACS reagent, ≥99.5%
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Acetonitrile, anhydrous, 99.8%
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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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