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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
Ammonia-14N, 99.99 atom % 14N
Sigma-Aldrich
Ammonia, puriss., anhydrous, ≥99.95%
Supelco
Tetraheptylammonium bromide, suitable for ion pair chromatography, LiChropur, ≥99.0% (AT)
Sigma-Aldrich
Tetraheptylammonium bromide, ≥99.0% (AT)
Sigma-Aldrich
Ammonia, anhydrous, ≥99.98%
Sigma-Aldrich
Phosphoric acid solution, 85 wt. % in H2O, FCC, FG
Sigma-Aldrich
Sodium sulfate, ≥99.0%, suitable for plant cell culture
Supelco
Residual Solvent - Acetonitrile(solution in DMSO), Pharmaceutical Secondary Standard; Certified Reference Material
Primaquine diphosphate, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Sodium hydroxide, puriss. p.a., ACS reagent, K ≤0.02%, ≥98.0% (T), pellets
Sigma-Aldrich
Primaquine bisphosphate, 98%
Sigma-Aldrich
Methanol, ACS reagent, ≥99.8%
Supelco
Methanol, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Methanol, ACS reagent, ≥99.8%
Sigma-Aldrich
Methanol, ACS spectrophotometric grade, ≥99.9%
Sigma-Aldrich
Chloroquine diphosphate salt, powder or crystals, 98.5-101.0% (EP)
Sigma-Aldrich
Ammonia solution, 0.4 M in dioxane
Sigma-Aldrich
Ammonia solution, 2.0 M in ethanol
Sigma-Aldrich
Ammonia solution, 4 M in methanol
Supelco
Acetonitrile(Neat), Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Sodium sulfate, tested according to Ph. Eur., anhydrous
Sigma-Aldrich
Sodium sulfate, BioXtra, ≥99.0%
Sigma-Aldrich
Sodium sulfate, ACS reagent, ≥99.0%, anhydrous, powder
Sigma-Aldrich
Sodium sulfate, ≥99.99% trace metals basis
Sigma-Aldrich
Sodium sulfate, ReagentPlus®, ≥99.0%
Sigma-Aldrich
Sodium sulfate, BioUltra, anhydrous, ≥99.0% (T)
Sigma-Aldrich
Sodium hydroxide, reagent grade, 97%, flakes
Supelco
Sodium hydroxide concentrate, 0.1 M NaOH in water (0.1N), Eluent concentrate for IC
Sigma-Aldrich
Sodium sulfate, ACS reagent, ≥99.0%, anhydrous, granular
Sigma-Aldrich
Sodium hydroxide, puriss., meets analytical specification of Ph. Eur., BP, NF, E524, 98-100.5%, pellets