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

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 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 individual capsules of amoxicillin analyzed, 13 were found to be substandard with total active pharmaceutical ingredients (API) lying outside the acceptable range of 90-110%. Of these 13, four were below 80% API. The FT-IR reliably identified these outliers and was found to yield results in good agreement with the established pharmacopeia liquid chromatography protocol. 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.

Figure 1.

Plot of the % deviation (%D) in content mass from each capsule, as a function of country of origin. The dashed lines represent the allowable %D.

Figure 2.

Plot of the % active pharmaceutical ingredients (API) for each capsule as determined by liquid chromatography–ultraviolet (LC–UV) analysis, as a function of country of origin. The dashed lines represent the acceptable limits in percentage API (%API).

Figure 3.

Plot of the % active pharmaceutical ingredients (API) for each capsule as determined by Fourier transform infrared (FT-IR) analysis, as a function of country of origin. The dashed lines represent the acceptable limits in percentage API (%API).

Figure 4.

Plot of the % active pharmaceutical ingredients (API) for each capsule as determined by Fourier transform infrared (FT-IR) analysis compared with that from liquid chromatography–ultraviolet (LC-UV). The solid line represents 1:1 agreement. The dashed box highlights the area of acceptable percentage API (%API).