dentification of artemether-lumefantrine combination drugs using mid-infrared spectroscopy and chemometric tools

The high circulation of substandard and/or falsified medicines is a major public health problem worldwide, particularly in low-resource countries. This work was carried out with the aim of combating this scourge using mid-infrared spectroscopy. The study focused on combination therapies based on artemether-lumefantrine and involved the construction and validation of a model for rapid detection of falsifications of artemether-lumefantrine. Other antimalarial drugs were also used to assess the specificity of the models constructed. A total of 46 samples were analyzed, all collected in Benin, from pharmacies in Departmental Hospital Centres and private pharmacies. The spectra recorded in the range from 4000 to 650 cm-1 were preprocessed then a principal component analysis was applied to break down and visualize the data, and to highlight groupings or trends. This enabled to observe the differences and similarities between the spectra of artemether/lumefantrine, and to assess the differentiating factors from other antimalarial molecules. Also, a data-driven soft independent modelling of class analogy (DD-SIMCA) model was built to evaluate its ability to authenticate artemether-lumefantrine samples. The other antimalarial drugs were used to test model specificity. Built DD-SIMCA model allowed a clear identification of artemether-lumefantrine (sensitivity 100%) and a good discrimination of other antimalarials (specificity 98%). Keywords: Quality control, construction, validation, DD-SIMCA.