Counterfeit pharmaceuticals are drugs or medications which are reproduced and sold with the intent to misrepresent their origin, authenticity, and effectiveness. The World Health Organization (WHO) has estimated that 10% of global pharmaceutical commerce, worth $21 billion, involves counterfeit drugs. In areas of lower income, counterfeit pharmaceuticals are most prevalent and cause the most life-threatening issues. The need for cheap, accessible medications has made many developing countries in Africa hotspots for counterfeit drug production. Doxycycline is an example of a commonly counterfeited antibiotic that is critical for the treatment of Malaria. Malaria has the highest transmission rates in Sub-Saharan Africa, accounting for 93% of the world’s Malaria deaths. Through a coalition with the University of Notre Dame Pharmaceutical Laboratory in Indiana, this study was conducted to determine the amount of active pharmaceutical ingredient (API) present in the doxycycline capsules sourced from Kenya, Uganda, and Papua New Guinea using HPLC-UV. Capsules were deemed to pass or fail based on a minus 10% API and plus 20% concentration range from the originally stated contents. To date, 66 doxycycline pills have been run with 59% having the FDA approved API and 41% of these samples failed, having substandard Doxycycline levels. Further, this study coupled API analysis with Fourier Transform Infrared (FTIR) spectroscopy analysis, to determine the identity of excipients present in doxycycline samples. Spectra were taken of the original powder from pill samples and water washed samples. The greatest percentage of excipients were identified to be talc or cellulose. Bromoethane-D5 and methanol were also identified at much lower spectrum match percentages. The FTIR methodology along with the HPLC analysis provide an in-depth examination and evaluation of a given doxycycline sample, which will help analyze and identify counterfeit and potentially harmful pharmaceuticals.

Quantitative investigation into potential counterfeit doxycycline

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