Analytical Tools and Strategic Approach to Detect Poor Quality Medicines, Identify Unknown Components, and Timely Alerts for Appropriate Measures: Case Study of Antimalarial Medicines
Védaste Habyalimana1,2, Jérémie Kindenge Mbinze1,3, Nicodème Kalenda Tshilombo1,3, Amandine Dispas1, Achille Yemoa Loconon1,4, Pierre-Yves Sacré1, Joëlle Widart5, Pascal De Tullio6, Stéphane Counerotte6, Justin-Léonard Kadima Ntokamunda7, Eric Ziemons1, Philippe Hubert1, Roland Marini Djang’eing’a1
1Department of Pharmacy, CIRM, Laboratory of Analytical Chemistry, Quartier Hôpital, University of Liege (ULg), Liège, Belgium.
2Rwanda Biomedical Center/Medical Procurement and Production Division, Butare, Rwanda.
3Faculté des Sciences Pharmaceutiques, Université de Kinshasa, Kinshasa XI, République Démocratique du Congo.
4Ecole de Pharmacie, Faculté des Sciences de la Santé, Université d’Abomey Calavi, Cotonou, Bénin.
5Department of Pharmacy, CIRM, Quartier Hôpital, University of Liege (ULg), Liège, Belgium.
6Department of Pharmacy, CIRM, Laboratory of Medicinal Chemistry, Quartier Hôpital, University of Liege (ULg), Liège, Belgium.
7School of Medicine and Pharmacy, University of Rwanda, Butare, Rwanda.
DOI: 10.4236/ajac.2015.613093   PDF   HTML   XML   3,369 Downloads   4,375 Views   Citations


Nowadays, the circulation of poor quality medicines is becoming an alarming worldwide phenomenon with serious public health and socio-economic concerns. The situation is particularly critical in developing countries where drug quality assurance and regulatory systems for drug manufacturing, importation, distribution and sales are weak. A sustained vigilance on poor quality medicines that regroup counterfeit/falsified, substandard and degraded medicines is therefore required to ensure patient safety and genuine medicines integrity. A case situation is illustrated including a strategic approach and analytical tools that were found useful to detect poor quality medicines, identify unknown components, and timely alerts for appropriate measures against the spread of those harmful products. Several suspected medicines randomly sampled in several strategic Rwandan areas were firstly check-controlled by means of visual inspection and then applying several analytical techniques from simple to more complex ones. The following medicines were studied: quinine sulfate tablets, artemisinin-based combination tablets, and artesunate powders for injection. Taking into account the pharmaceutical forms and the chemical characteristics, the following tests were applied: uniformity of mass, friability, disintegration, fluorescence, identification and assay. They were followed by more complex analytical techniques that allowed more comprehension of abnormal findings among which the presence of a wrong active pharmaceutical ingredient in quinine sulfate tablets which is mainly discussed in this paper to illustrate a strategic approach and various analytical tools that can be used in detecting and identifying unknown component in poor quality medicines.

Share and Cite:

Habyalimana, V. , Mbinze, J. , Tshilombo, N. , Dispas, A. , Loconon, A. , Sacré, P. , Widart, J. , De Tullio, P. , Counerotte, S. , Ntokamunda, J. , Ziemons, E. , Hubert, P. and Djang’eing’a, R. (2015) Analytical Tools and Strategic Approach to Detect Poor Quality Medicines, Identify Unknown Components, and Timely Alerts for Appropriate Measures: Case Study of Antimalarial Medicines. American Journal of Analytical Chemistry, 6, 977-994. doi: 10.4236/ajac.2015.613093.

Conflicts of Interest

The authors declare no conflicts of interest.


[1] (2008) Sanofi-Aventis, Press Pack: Drug Counterfeiting.
[2] World Health Organization (WHO) (1999) Counterfeit Drugs: Guidelines for the Development for Measures to Combat Counterfeit Drugs.
[3] World Health Organization (WHO) Fact Sheet Revised (2006) Essential Medicines and Health Products—Counterfeit Medicines.
[4] The Financial Times by Joseph Milton (2012) Fake Medicines: Illegal, Immoral and Liable to Increase Drug Resistance.
[5] Newton, P.N., Amin, A.A., Bird, C., Passmore, P., Dukes, G., et al. (2011) The Primacy of Public Health Considerations in Defining Poor Quality Medicines. PLoS Medicine, 8, e1001139.
[6] International Council of Nurses (ICN), United States Pharmacopoeia (USP), International Pharmaceutical Federation (FIP) (2014) Tool for Visual Inspection of Medicines.
[7] Deconinck, E., Sacré, P.Y., Courselle, P. and De Beer, J.O. (2013) Chromatography in the Detection and Characterization of Illegal Pharmaceutical Preparations. Journal of Chromatographic Science, 51, 791-806.
[8] Monge, M.E., Dwivedi, P., Zhou, M., Payne, M., Harris, C., et al. (2014) A Tiered Analytical Approach for Investigating Poor Quality Emergency Contraceptives. PLoS ONE, 9, e95353.
[9] Fernandez, F.M., Hostetler, D., Powell, K., Kaur, H., Green, M.D., Mildenhall, D.C. and Newton, P.N. (2011) Poor Quality Drugs: Grand Challenges in High Throughput Detection, Countrywide Sampling, and Forensics in Developing Countries. Analyst, 136, 3073-3082.
[10] Dégardin, K., Roggo, Y. and Margot, P. (2014) Understanding and Fighting the Medicine Counterfeit Market. Journal of Pharmaceutical and Biomedical Analysis, 87, 167-175.
[11] Kaur, H., Green, M.D., Hostetler, D.M., Fernáández, F.M. and Newton, P.N. (2010) Antimalarial Drug Quality: Methods to Detect Suspect Drugs. Therapy, 7, 49-57.
[12] Pathirana, C., Bolgar, M.S., Peddicord, M.B., Miller, A.S. and Shackman, M.H. (2014) Application of Mass Spectrometry to Support Verification and Characterization of Counterfeit Pharmaceuticals. LC-GC Special Issue on Currents Trends in Mass Spectrometry.
[13] Sacré, P.Y., Deconinck, E., De Beer, T., Courselle, P., Vancauwenberghe, R., Chiap, P., Crommen, J. and De Beer, J.O. (2010) Comparison and Combination of Spectroscopic Techniques for the Detection of Counterfeit Medicines. Journal of Pharmaceutical and Biomedical Analysis, 53, 445-453.
[14] Roggo, Y., Degardin, K. and Margot, P. (2010) Identification of Pharmaceutical Tablets by Raman Spectroscopy and Chemometrics. Talanta, 81, 988-995.
[15] Dégardin, K., Roggo, Y., Been, F. and Margot, P. (2011) Detection and Chemical Profiling of Medicine Counterfeits by Raman Spectroscopy and Chemometrics. Analytica Chimica Acta, 705, 334-341.
[16] Marini, R.D., Rozet, E., Montes, M.L., Rohrbasser, C., Roht, S., Rhème, D., Bonnabry, P., Schappler, J., Veuthey, J.L., Hubert, P. and Rudaz, S. (2010) Reliable Low-Cost Capillary Electrophoresis Device for Drug Quality Control and Counterfeit Medicines. Journal of Pharmaceutical and Biomedical Analysis, 53, 1278-1287.
[17] Mustazza, C., Borioni, A., Rodomonte, A.L., Bartolomei, M., Antoniella, E., Di Martino, P., Valvo, L., Sestili, I., Costantini, E. and Gaudiano, M.C. (2014) Characterization of Sildenafil Analogs by MS/MS and NMR: A Guidance for Detection and Structure Elucidation of Phosphodiesterase-5 Inhibitors. Journal of Pharmaceutical and Biomedical Analysis, 96, 170-186.
[18] Wiest, J., Schollmayer, C., Gresser, G. and Holzgrabe, U. (2014) Identification and Quantitation of the Ingredients in a Counterfeit Vietnamese Herbal Medicine against Rheumatic Diseases. Journal of Pharmaceutical and Biomedical Analysis, 97, 24-28.
[19] Rwanda National Police News, RNP Committed to Fighting Illicit Pharmaceuticals—ACP Kuramba, 7 February 2015.[tt_news]=3591&cHash=ac2ccbcdf8f365d0b6d815206830a6aa
[20] International Institute of Research Against Counterfeit Medicines (IRACM), A Specialized Unit Is Focused on the Fight against Fake Drugs and Counterfeiting in Rwanda (Posted on 9 March 2015).
[21] MSH/WHO, International Drug Price Indicator Guide, 2013.

Copyright © 2023 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.