Detection of Substandard and Falsified Antibiotics Sold in the Democratic Republic of the Congo Using Validated HPLC and UV-Visible Spectrophotometric Methods.

The access to afford safe, effective, and genuine medications is a major challenge for people in low- to middle-income countries. This study aimed at developing and validating simple, accurate, and inexpensive analytical liquid chromatography and ultraviolet-visible spectrophotometric methods to ensure quality control of antibiotics sold in formal and informal pharmaceutical markets. It focused on four antibiotics (azithromycin [AZT], cefadroxil [CFD], cefixime [CFX], and erythromycin [ERH]) used to treat infectious diseases in the region of Haut-Katanga in the Democratic Republic of the Congo (DRC). The total error strategy (accuracy profile) matching with the validation requirements of International Council on Harmonization was used for the validation. The validation results showed that three analytical methods of AZT, CFD, and ERH were validated according to the accuracy profile obtained, whereas the proposed method of CFX was not validated. Therefore, the United State Pharmacopoeia method permitted to quantify CFX samples. The dosage intervals ranged from 25 to 75 µg/mL for CFD, from 750 to 1,500 µg/mL for AZT, and from 500 to 750 µg/mL for ERH. The application of the validated method to samples collected (N = 95) allowed the detection of 25% substandard antibiotics with a rate of poor quality much higher in the informal circuit compared with the formal one (54% versus 11%; P < 0.05). The routine application of these methods will strengthen the quality control of drugs marketed in DRC. This study gives evidence for the availability of poor-quality antibiotics in the country, requiring the immediate attention of the national medicine regulatory authority.

Bio-surveillance of environmental pollutants in the population of Kinshasa, Democratic Republic of Congo (DRC): a small pilot study.

BACKGROUND: Environmental pollutants are known to be ubiquitous and may present toxic effects (endocrine-disruption properties, carcinogenicity …) and represent a real threat to human health. The aim of the present pilot study was to assess the content of environmental pollutants (inorganic, persistent, and non-persistent pollutants) in biological samples (urine, serum, and whole blood), collected from volunteers in Kinshasa, capital of Democratic Republic of Congo, in order to identify pollutants of interest and to design a protocol for a larger scale study. METHODS: From randomly selected 15 volunteers living in Kinshasa, aged from 25 to 66 years, (mean age = 43.4 years), including 10 men and 5 women, urine, whole blood, and serum samples were used in this study to estimate the contents in these environmental pollutants, using inductively coupled plasma mass spectrometry, gas chromatography coupled to mass spectrometry, and liquid chromatography coupled to mass spectrometry. RESULTS: When compared to data nationally and internationally available, the preliminary outcomes of this study indicated a very high level of exposure to environmental pollutants in the population of Kinshasa, especially for heavy metals, parabens and triclosan. To a lesser extent, contamination measured for glyphosate, phthalates, organochlorine pesticides, pyrethroids and dialkylphosphate pesticides was also significant. In contrast, the investigated population of Kinshasa was found to be weakly exposed to other persistent organic pollutants like polychlorinated biphenyls, brominated flame retardants, phenolic organohalogens, and perfluoroalkyl substances. CONCLUSION: Although the biologic fluids were collected from a limited number of volunteers (n = 15), the results of the present report clearly indicate that the population of Kinshasa is not spared by the investigated environmental pollutants. Moreover, this study gives us important information to design a larger scale study protocol.