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Simple LC Isocratic Methods Development, validation, and Application in the Analysis of Poor Quality Antimalarial Medicines

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American Journal of Analytical Chemistry 2017年第9期8卷 582-603页

作者： védaste habyalimana Jérémie Kindenge Mbinze Achille Loconon Yemoa Justin-Léonard Kadima Ntokamunda Philippe Hubert Roland Marini Djang’eing’a Laboratory of Pharmaceutical Analytical Chemistry CIRM University of Liège (ULg) Liège Belgium Rwanda Biomedical Center/Medical Procurement and Production Division Kigali Rwanda Faculty of Pharmaceutical Sciences University of Kinshasa Kinshasa XI Democratic Republic of Congo Faculty of Health Sciences School of Pharmacy University of Abomey Calavi Cotonou Benin School of Medicine and Pharmacy University of Rwanda Butare Rwanda

Liquid chromatographic methods in isocratic mode for the analysis of poor quality medicines are privileged due to their simplicity and facility in methods development. They are generally fast;do not need to be re-equilibrated between sample injections;have larger flexibility with acceptable changes on different column dimensions;and are applicable to LC systems equipped with simple or high developed pumps. In this study, we focused on developing simple isocratic methods using classical mobile phase composed by methanol and ammonium formate buffer for the analysis of most common antimalarial medicines marketed in malaria endemic countries and susceptible of being counterfeit/falsified, substandard and degraded. The selected medicines were quinine and related cinchona alkaloids in tablets and injectable forms;artemether/lumefantrine tablets;and artemisinin compounds (arteether, artemether, and artesunate) in injectable forms. The current methods were developed thanks to simple methodological approach consisting in sequential isocratic runs through adjustment or adaptation of existing methods to obtain optimal analytical conditions without complex design of experiments that might be long and costly. Then, the new methods presented shorter analysis time;allowed increase of sample analysis throughput;and obviously consumed little mobile phase solvents on classical analytical columns: 50 - 250 mm of length (L), 4.6 mm of internal diameter (I.D.), and 3.5 - 5.0 μm of particle size (dp).

关键词： Antimalarial Medicines Liquid Chromatography Isocratic Mode validation Poor Quality Medicines

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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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American Journal of Analytical Chemistry 2015年第2期6卷 127-144页

作者： Jérémie Kindenge Mbinze Achille Yemoa Pierre Lebrun Pierre-Yves Sacré védaste habyalimana Nicodème Kalenda André Bigot Eugène Atindehou Philippe Hubert Roland Djang’eing’a Marini University of Liege (ULg) Department of Pharmacy CIRM Laboratory of Analytical Chemistry Li&egrave ge Belgium Laboratoire d’Analyse des Mé dicaments D&eacute partement de Galé nique et d’Analyse des Mé dicaments Universit&eacute de Kinshasa Kinshasa XI Democratic Republic of Congo UFR Pharmacie Facult&eacute des Sciences de Santé Universit&eacute d’Abomey Calavi Cotonou B&eacute nin Rwanda Biomedical Center Medical Procurement and Production Division Butare Rwanda Université Fé lix Houphouet Boigny Abidjan C&ocirc te d’Ivoire

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.

关键词： Antimalarial ACT Simultaneous Determination Poor Quality Substances Design of Experiments Design Space Method Transfer Accuracy Profile

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Investigation of the Quality of Antibiotics-Based Amoxicillin for Monitoring of Some Different Medicine Markets of Democratic Republic of Congo

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American Journal of Analytical Chemistry 2018年第8期9卷 366-385页

作者： Nicodème Kalenda Tshilombo Patient Ciza Hamuli Jérémie K. Mbinze védaste habyalimana Dibungi T. Kalenda Don Jethro Mavungu Pierrot Mwamba Philippe Hubert Roland Djang’eing’a Marini Laboratory of Analytical Chemistry CIRM Department of Pharmacy Liege University Liège Belgium Laboratory of Chromatography Faculty of Pharmaceutical Sciences University of Kinshasa Kinshasa Democratic Republic of Congo Laboratory of Drug Analysis Department of Galenic Pharmacy University of Kinshasa Kinshasa Democratic Republic of Congo Medical Procurement and Production Division Rwanda Biomedical Center Kigali Rwanda Laboratory of Pharmacognosy CIRM Department of Pharmacy Liege University Liège Belgium Ecole Régionale Postuniversitaire d’Aménagement et de Gestion Intégrée des Forêts et Territoires Tropicaux University of Kinshasa Kinshasa Democratic Republic of Congo Department 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.

关键词： Poor Quality Medicines Amoxicillin LC Method validation Survey Study

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Analytical Tools and Strategic Approach to Detect Poor Quality Medicines, Identify Unknown Components, and Timely Alerts for Appropriate Measures: Case Study of Antimalarial Medicines

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American Journal of Analytical Chemistry 2015年第13期6卷 977-994页

作者： vé daste habyalimana Jé ré mie Kindenge Mbinze Nicod&egrave me Kalenda Tshilombo Amandine Dispas Achille Yemoa Loconon Pierre-Yves Sacré Joë lle Widart Pascal De Tullio Sté phane Counerotte Justin-Lé onard Kadima Ntokamunda Eric Ziemons Philippe Hubert Roland Marini Djang&rsquo eing&rsquo a Department of Pharmacy CIRM Laboratory of Analytical Chemistry Quartier H&ocirc pital University of Liege (ULg) Liège Belgium Rwanda Biomedical Center/Medical Procurement and Production Division Butare Rwanda Faculté des Sciences Pharmaceutiques Université de Kinshasa Kinshasa XI République Démocratique du Congo Ecole de Pharmacie Faculté des Sciences de la Santé Université d’Abomey Calavi Cotonou Bénin Department of Pharmacy CIRM Quartier H&ocirc pital University of Liege (ULg) Liège Belgium Department of Pharmacy CIRM Laboratory of Medicinal Chemistry Quartier H&ocirc pital University of Liege (ULg) Liège Belgium School of Medicine and Pharmacy University of Rwanda Butare Rwanda

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.

关键词： Poor Quality Medicines Antimalarial Medicines visual Inspection Simple and Complex Analytical Tools

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