Toward Point-of-Care Drug Quality Assurance in Developing Countries: Comparison of Liquid Chromatography and Infrared Spectroscopy Quantitation of a Small-Scale Random Sample of Amoxicillin, Ciprofloxacin and Doxycycline

Abstract

Substandard antibiotics are thought to be a major threat to public health in developing countries and a cause of antimicrobial resistance. However, assessing quality outside of a laboratory setting, using simple equipment, is challenging. The aim of this study was to validate the use of a portable Fourier transform infrared (FT-IR) spectrometer for the identification of substandard antibiotics. Results are presented for amoxicillin, ciprofloxacin, and doxycycline packages from Haiti, Ghana, Sierra Leone, Democratic Republic of Congo, India, Papua New Guinea, and Ethiopia collected over the course of 6 months in 2017, including two field trips with the FT-IR to Ghana and Sierra Leone. Canadian samples were used as a control. Regarding drug quality, of 290, 280, and 42 individual capsules and tablets of amoxicillin, ciprofloxacin, and doxycycline analyzed, 13, 14, and 27 respectively were found to be substandard with total active pharmaceutical ingredients (API) lying outside the acceptable range of 90–110%. The FT-IR reliably identified the outliers of amoxicillin and ciprofloxacin and was found to yield results in good agreement with the established pharmacopeia liquid chromatography protocol. Results for doxycycline were less promising, but LC-UV analysis was also found to be problematic. We conclude that the portable FT-IR may be suitable to intercept substandard antibiotics in developing countries where more sophisticated techniques are not readily available.