The World Health Organization defines a counterfeit medicine as a pharmaceutical whose active ingredient is either under-dosed or completely absent. The worldwide counterfeit business was able to sell more than 200 billion dollars in counterfeit pharmaceuticals in the last few years. Communities which are particularly affected are those in which analytical resources, such as trained pharmacists or analytical instruments, are scarce. In these areas, Paper Analytical Devices (PADs), which involve simple colorimetric chemical tests on a paper-based device, can provide a screening method for the pharmaceuticals available. These PADs have been designed to provide an inexpensive and practical method for this front line drug screening. The PADs yield a quick identification of ingredients found in genuine and/or counterfeit drugs. For pharmaceuticals that are commonly under-dosed the PADs will offer a semi-quantitative analysis of the active ingredients. Macrolide antibiotics such as azithromycin and erythromycin are often found to be under-dosed or expired. Preliminary laboratory tests have yielded qualitative colorimetric tests which react with various functional groups on these antibiotics. In addition, both azithromycin and erythromycin have been found to react semi-quantitatively with sulfuric acid. Progress has been made towards finding instrumental methods using UPLC-UV and UPLC-MS analyses to quantify samples of azithromycin and erythromycin. These methods are being used to validate results obtained from tests carried out using PADs.

Development of paper analytical devices for the detection of substandard azithromycin and erythromycin

249th National Meeting (2015)

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