Development of simplified HPLC methods for the detection of counterfeit antimalarials in resource-restraint environments

• Very simple liquid chromatographic methods for the analysis of antimalarial agents were developed.
• A high grade of ruggedness allows them to be used in tropical environments.
• Only C18 silica columns, methanol and simple phosphate buffers are required.
• The methods can quantify the active ingredient, resolve distinct impurities and reveal replacements.
• The concepts described here may facilitate routine pharmaceutical quality control in the developing world.

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.

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