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Fighting Poor Quality Medicines: Development, Transfer and Validation of Generic HPLC Methods for Analyzing Two WHO Recommended Antimalarial Tablets

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ABSTRACT
As serious but neglected public health problems, poor quality medicines, i.e. for antimalarial medicines, urged to be fought. One of the approaches is to consider the analytical chemistry and separative techniques. In this study, a generic liquid chromatographic method was firstly developed for the purpose of screening 8 antimalarial active ingredients, namely amodiaquine (AQ), piperaquine (PPQ), sulfalene (SL), pyrimethamine (PM), lumefantrine (LF), artesunate (AS), artemether (AM) and dihydroartemisinine (DHA) by applying DoE/DS optimization strategy. Since the method was not totally satisfying in terms of peak separation, further experiments were undergone applying the same development strategy while splitting the 8 ingredients into five groups. Excellent prediction was observed prior to correlation between retention times of predicted and observed separation conditions. Then, a successful geometric transfer was realized to reduce the analysis time focusing on the simultaneous quantification of two WHO’s recommended ACTs in anti-malarial fixed-dose combination (AM-LF and AS-AQ) in tablets. The optimal separation was achieved using an isocratic elution of methanol-ammonium formate buffer (pH 2.8; 10 mM) (82.5:17.5, v/v) at 0.6 ml/min through a C18 column (100 mm × 3.5 mm, 3.5 μm) thermostated at 25℃. After a successful validation stage based on the total error approach, the method was applied to determine the content of AM/LF or AS/AQ in seven brands of antimalarial tablets currently marketed in West, Central and East Africa. Satisfying results were obtained compared to the claimed contents.
 
Cite this paper
Mbinze, J. , Yemoa, A. , Lebrun, P. , Sacré, P. , Habyalimana, V. , Kalenda, N. , Bigot, A. , Atindehou, E. , Hubert, P. and Marini, R. (2015) Fighting Poor Quality Medicines: Development, Transfer and Validation of Generic HPLC Methods for Analyzing Two WHO Recommended Antimalarial Tablets. American Journal of Analytical Chemistry, 6, 127-144. doi: 10.4236/ajac.2015.62012.
 
References
[1]World Health Organization (2013) World Malaria Report 2013. WHO Press, Geneva.
 
[2]Malaria Consortium (2014) Artemisinin-Based Combination Therapy.
http://www.malariaconsortium.org
 
[3]World Health Organization (2014) Substandard and Counterfeit Medicines.
http://www.who.int/mediacentre/factsheets/2003/fs275/en/
 
[4]Newton, P.N., Dondorp, A., Green, M., Mayxay, M. and White, N.J. (2003) Counterfeit Artesunate Antimalarials in Southeast Asia. Lancet, 362, 169.
http://dx.doi.org/10.1016/S0140-6736(03)13872-X
 
[5]Mbinze, J.K., Dispas, A., Lebrun, P., Mavar Tayey Mbay, J., Habyalimana, V., Kalenda, N., Rozet, E., Hubert, P. and Marini, R.D. (2013) Application of an Innovative Design Space Optimization Strategy to the Development of LC Methods for the Simultaneous Screening of Antibiotics to Combat Poor Quality Medicines. Journal of Pharmaceutical and Biomedical Analysis, 85, 83-92.
http://dx.doi.org/10.1016/j.jpba.2013.06.036
 
[6]Mbinze, J.K., Lebrun, P., Debrus, B., Dispas, A., Kalenda, N., Mavar Tayey Mbay, J., Schofield, T., Boulanger, B., Rozet, E., Hubert, Ph. and Marini, R.D. (2012) Application of Aninnovative Design Space Optimization Strategy to the Development of Liquid Chromatographic Methods to Combat Potentially Counterfeit Nonsteroidal Anti-Inflammatory Drugs. Journal of Chromatography A, 1263, 113-124.
http://dx.doi.org/10.1016/j.chroma.2012.09.038
 
[7]Habyalimana, V., Kalenda Tshilombo, N., Dispas, A., Mbinze, J.K., Kadima Ntokamunda, J.L., Lebrun, P., Hubert, P. and Marini Djang’eing’a, R. (2014) Méthodes chromatographiques génériques de criblage pour lutter contre les médicaments de qualité inférieure. Spectra Analyse, 298, 30-36.
 
[8]Debrus, B., Lebrun, P., Kindenge, J.M., Lecomte, F., Ceccato, A., Caliaro, G., Mbay, J.M., Boulanger, B., Marini, R.D., Rozet, E. and Hubert, Ph. (2011) Innovative High-Performance Liquid Chromatography Method Development for the Screening of 19 Antimalarial Drugs Based on a Generic Approach, Using Design of Experiments, Independent Component Analysis and Design Space. Journal of Chromatography A, 1218, 5205-5215.
http://dx.doi.org/10.1016/j.chroma.2011.05.102
 
[9]International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q8 (R2) (2009) Pharmaceutical Development. Geneva.
 
[10]Lebrun, P., Govaerts, B., Debrus, B., Ceccato, A., Caliaro, G., Hubert, Ph. and Boulanger, B. (2008) Development of a New Predictive Modeling Technique to Find with Confidence Equivalence Zone and Design Space of Chromatographic Analytical Methods. Chemometrics and Intelligent Laboratory Systems, 91, 4-16.
http://dx.doi.org/10.1016/j.chemolab.2007.05.010
 
[11]Dewé, W., Marini, R.D., Chiap, P., Hubert, P., Crommen, J. and Boulanger, B. (2004) Development of Response Models for Optimising HPLC Method. Chemometrics and Intelligent Laboratory Systems, 74, 263-268.
http://dx.doi.org/10.1016/j.chemolab.2004.04.016
 
[12]Debrus, B., Lebrun, P., Ceccato, A., Caliaro, G., Rozet, E., Nistor, I., Oprean, R., Rupérez, F.J., Barbas, C., Boulanger B. and Hubert, P. (2011) Application of New Methodologies Based on Design of Experiments, Independent Component Analysis and Design Space for Robust Optimization in Liquid Chromatography. Analytica Chimica Acta, 691, 33-42.
http://dx.doi.org/10.1016/j.aca.2011.02.035
 
[13]Memvanga, P.B., Mbinze, J.K., Rozet, E., Hubert, P., Préat, V. and Marini, R.D. (2014) Development of a Liquid Chromatographic Method for the Simultaneous Quantification of Curcumin, β-Arteether, Tetrahydrocurcumin and Dihydroartemisinin. Application to Lipid-Based Formulations. Journal of Pharmaceutical and Biomedical Analysis, 88, 447-456.
http://dx.doi.org/10.1016/j.jpba.2013.09.009
 
[14]US Pharmacopeia (2014) USP 37-NF 32. www.uspnf.com
 
[15]International Pharmacopoeia (2007) Working Document QAS/07.197/Rev.1.
 
[16]Guillarme, D., Nguyen, D., Rudaz, S. and Veuthey, J.L. (2007) Method Transfer for Fast Liquid Chromatography in Pharmaceutical Analysis: Application to Short Columns Packed with Small Particle. Part I: Isocratic Separation. European Journal of Pharmaceutics and Biopharmaceutics, 66, 475-482.
http://dx.doi.org/10.1016/j.ejpb.2006.11.027
 
[17]Hubert, P., Nguyen-Huu, J.J., Boulanger, B., Chapuzet, E., Cohen, N., Compagnon, P.A., Dewé, W., Feinberg, M., Laurentie, M., Mercier, N., Muzard, G., Valat, L. and Rozet, E. (2007) Harmonization of Strategies for the Validation of Quantitative Analytical Procedures: A SFSTP Proposal—Part III. Journal of Pharmaceutical and Biomedical Analysis, 45, 82-96.
http://dx.doi.org/10.1016/j.jpba.2007.06.032
 
[18]Hubert, P., Nguyen-Huu, J.J., Boulanger, B., Chapuzet, E., Cohen, N., Compagnon, P.A., Dewé, W., Feinberg, M., Laurentie, M., Mercier, N., Muzard, G., Valat, L. and Rozet, E. (2008) Harmonization of Strategies for the Validation of Quantitative Analytical Procedures: A SFSTP Proposal: Part IV. Examples of Application. Journal of Pharmaceutical and Biomedical Analysis, 48, 760-771.
http://dx.doi.org/10.1016/j.jpba.2008.07.018
 
[19]Food and Drug Administration (1995) International Conference on Harmonization: Guideline on Validation of Analytical Procedures: Definitions and Terminology. Federal Register, 60, 11260-11262
 
[20]Hubert, P., Nguyen-Huu, J.J., Boulanger, B., Chapuzet, E., Chiap, P., Cohen, N., Compagnon, P.A., Dewe, W., Feinberg, M., Lallier, M., Laurentie, M., Mercier, N., Muzard, G., Nivet, C. and Valat, L. (2003) Validation des procédures analytiques quantitatives Harmonisation des démarches. STP Pharma Pratiques, 13, 101-138.
 
[21]Boulanger, B., Rozet, E., Moonen, F., Rudaz, S. and Hubert, P. (2009) A Risk-Based Analysis of the AAPS Conference Report on Quantitative Bioanalytical Methods Validation and Implementation. Journal of Chromatography B, 877, 2235-2243.
http://dx.doi.org/10.1016/j.jchromb.2009.06.019
 
[22]The European Medicines Agency (1996) Note for Guidance on Manufacture of the Finished Dosage Form.
www.ema.europa.eu/docs/en_GB/document_library/
Scientific_guideline/2009/09/WC500002916.pdf                                                         eww150122lx
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