[en] NSAIDs ; Substandard and Counterfeit drugs ; Design of experiments ; Design space ; Method transfer ; Accuracy profile
[en] In the context of the battle against counterfeit medicines, an innovative methodology has been used to develop rapid and specific high performance liquid chromatographic methods to detect and determine 18 non-steroidal anti-inflammatory drugs, 5 pharmaceutical conservatives, paracetamol, chlorzoxazone, caffeine and salicylic acid. These molecules are commonly encountered alone or in combination on the market. Regrettably, a significant proportion of these consumed medicines are counterfeit or substandard, with a strong negative impact in countries of Central Africa. In this context, an innovative design space optimization strategy was successfully applied to the development of LC screening methods allowing the detection of substandard or counterfeit medicines. Using the results of a unique experimental design, the design spaces of 5 potentially relevant HPLC methods have been developed, and transferred to an ultra high performance liquid chromatographic system to evaluate the robustness of the predicted DS while providing rapid methods of analysis. Moreover, one of the methods has been fully validated using the accuracy profile as decision tool, and was then used for the quantitative determination of three active ingredients and one impurity in a common and widely used pharmaceutical formulation. The method was applied to 5 pharmaceuticals sold in the Democratic Republic of Congo. None of these pharmaceuticals was found compliant to the European Medicines Agency specifications
Centre Interfacultaire de Recherche du Médicament
Commission universitaire pour le Développement - CUD; Walloon Region of Belgium; Belgium National Fund for Scientific Research (FRS-FNRS)
Researchers ; Professionals ; Students ; General public
The manuscript highlights a combination of two aspects, analytical method development leading to analytical tools and counterfeit of medicines that corrupts the world and in particular low-income countries that have very low or even no means to combats this scourge.