Author(s)

Nicodème Kalenda Tshilombo^1,2, Patient Ciza Hamuli^1,3, Jérémie K. Mbinze³, Védaste Habyalimana⁴, Dibungi T. Kalenda², Don Jethro Mavungu^5,6, Pierrot Mwamba⁷, Philippe Hubert¹, Roland Djang’eing’a Marini^1*

¹Laboratory of Analytical Chemistry, CIRM, Department of Pharmacy, Liege University, Liège, Belgium.
²Laboratory of Chromatography, Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa, Democratic Republic of Congo.
³Laboratory of Drug Analysis, Department of Galenic Pharmacy, University of Kinshasa, Kinshasa, Democratic Republic of Congo.
⁴Medical Procurement and Production Division, Rwanda Biomedical Center, Kigali, Rwanda.
⁵Laboratory of Pharmacognosy, CIRM, Department of Pharmacy, Liege University, Liège, Belgium.
⁶Ecole Régionale Postuniversitaire d’Aménagement et de Gestion Intégrée des Forêts et Territoires Tropicaux, University of Kinshasa, Kinshasa, Democratic Republic of Congo.
⁷Department of Pharmacy Galenic, University of Lubumbashi, Lubumbashi, Democratic Republic of Congo.

In order to combat the counterfeiting of drugs, adapted HPLC analytical USP methods were applied to evaluate the quality of the amoxicillin (with or without potassium clavulanate) powder for suspension sold in some Congolese markets. The adaptation has been done by modifying the column dimensions and adjusting the flow rate. According to the intended deployment of these methods in Democratic Republic of Congo (DRC), 3 factors (analyst, day and equipment) were involved in the validation step while applying the classic total error measurement approach with an accuracy profile as decision tool. Since adequate results were obtained in terms of selectivity, precision, trueness and accuracy (tolerance limits of life expectancy: −6.0% and 3.8%) for levels of interest concentration, the methods have been considered for routine use on several samples from different provenances and collected in 4 major DRC cities. Out of 278 samples collected, 200 were eligible for analysis from which 28% were found under standards with several figures: pH failure, out of specification for amoxicillin content, absence of potassium clavulanate, physical modifications of the powders. As evidenced by these findings, medicines of low-quality continue to be a major public health problem requiring appropriate action to effectively address this problem.

Poor Quality Medicines, Amoxicillin, LC Method, Validation, Survey Study

Tshilombo, N. , Hamuli, P. , Mbinze, J. , Habyalimana, V. , Kalenda, D. , Mavungu, D. , Mwamba, P. , Hubert, P. and Marini, R. (2018) Investigation of the Quality of Antibiotics-Based Amoxicillin for Monitoring of Some Different Medicine Markets of Democratic Republic of Congo. American Journal of Analytical Chemistry, 9, 366-385. doi: 10.4236/ajac.2018.98029.