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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

Performance of Sickle SCAN<sup>®</sup>in the Screening of Sickle Cell Disease in Kisangani Pregnant Women and Attitude towards Results

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Open Journal of Blood Diseases 2020年第2期10卷 23-36页

作者： Yvette Neema-Ufoy Mungu Jean Jeannot Juakali-Sihalikyolo roland djang’eing’a marini Gédéon Katenga-Bosunga Hermane Avohou-Tonakpon Stéphane Leduc Franç ois Boemer Salomon Batina-Agasa Department of Obstetrics and Gynecology Kisangani University Clinics University of Kisangani Kisangani The Democratic Republic of the Congo Department of Pharmaceutical Sciences Faculty of Medicine and of Pharmacy Kisangani The Democratic Republic of the Congo Laboratory of Pharmaceutical and Analytical Chemistry Department of Pharmacy CIRM University of Liege Liege Belgium Laboratory of Biochemistry and Human Genetics University Hospital of Liege Liege Belgium Department of Internal Medicine Kisangani University Clinics Kisangani The Democratic Republic of the Congo

In the Democratic Republic of the Congo, the sickle cell trait carriage is estimated at 25%. Routine neonatal screening is not a common practice, leading to a very late diagnosis. In this study, the screening of pregnant women was assessed as well as their attitudes. This is an analytical cross-sectional study conducted in 245 pregnant women, sampled by convenience in four hospitals in Kisangani city (Democratic Republic of Congo) and screened using the sickle SCAN® test, from February 1 to July 31, 2019. The sensitivity and specificity of the latter were determined using liquid chromatography coupled with mass spectrometry as the gold standard. The attitudes of 240 pregnant women without previous screening history were assessed upon the announcement of the results. The sensitivity of screening for hemoglobin (Hb) AA and Hb AS was 96.69% and 98.39%, respectively;while the specificities were 99.43% and 96.32%, respectively. The Kappa coefficient (κ) was excellent. Concerning attitudes, Hb SS pregnant women and 55.17% of AS pregnant women worried when the results relating to their hemoglobin status were announced. The sickle SCAN® test was found reliable for sickle cell disease screening in Kisangani. The announcement of the results, mainly positive, raises worry among pregnant woman. Therefore, we recommend the involvement of a clinician psychologist for pre-screening counselling and for results announcement, as well as early newborns and unmarried teenage girls screening.

关键词： Sickle SCAN® Liquid Chromatography Pregnant Women Attitudes Kisangani

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

Application of Total Error Strategy in Validation of Affordable and Accessible UV-Visible Spectrophotometric Methods for Quality Control of Poor Medicines

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American Journal of Analytical Chemistry 2015年第2期6卷 106-117页

作者： Jérémie Kindenge Mbinze Jean Nsangu Mpasi Elza Maghe Sébastien Kobo Rodrigue Mwanda Guy Mulumba Jacquie Bolavie Bolande Trésor Menanzambi Bayebila Maguy Borive Amani Philippe Hubert roland djang’eing’a marini University of Liege (ULg) Department of Pharmacy CIRM Laboratory of Analytical Chemistry Li&egrave ge Belgium Laboratory of Drug Analysis Faculty of Pharmaceutical Sciences University of Kinshasa Kinshasa Democratic Republic of Congo Laboratory Service Institute of Research in Science of Health Kinshasa Democratic Republic of Congo Faculty of Medicine and Pharmacy University of Kisangani Kisangani Democratic Republic of Congo

In the framework of fighting against the poor quality medicines sold in developing countries using classical analytical methods easily accessible in those countries, four UV-Visible spectrophotometric methods for one antimalarial (quinine) and two antibiotics (amoxicillin and metronidazole) have been developed and validated according to the total error strategy using the accuracy profiles as a decision tool. The dosing range was 2 - 10 μg/mL (for quinine sulfate in tablet), 4 - 12 μg/mL (for quinine bichlorhydrate in oral drop-metronidazole benzaote in oral suspension) and 15 - 35 μg/mL (for amoxicillin trihydrate in capsule). The validated methods were then applied in determining the content of some analogous medicines sold in the Democratic Republic of Congo. Thus, the proposed UV-Visible spectrophotometric methods are simple and suitable to quantify quinine, amoxicillin and metronidazole in different pharmaceutical forms.

关键词： Poor Quality Medicines UV-Visible Spectrophotometric Methods Quinine Amoxicillin Metronidazole Validation Total Error Accuracy Profiles

Quality Control of Paracetamol Generic Tablets Marketed in Benin and Search of Its Two Impurities P-Aminophenol and P-Nitrophenol by HPLC-UV/Visible

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American Journal of Analytical Chemistry 2022年第11期13卷 449-460页

作者： Yemoa Loconon Achille Agbokponto Janvier Engelbert Assanhou Assogba Gabin Adetona Pauline Doffon Parfait Ganfon Habib roland marini djang’eing’a Laboratoire de Chimie analytique et Analyse des Médicaments Unité de Formation et de Recherche en Pharmacie Faculté des Sciences de la Santé. Université d’Abomey Calavi Cotonou Bénin Laboratoire de Pharmacie Galénique et de Technologie Pharmaceutique Unité de Formation et de Recherche en Pharmacie Faculté des Sciences de la Santé Université d’Abomey Calavi Cotonou Bénin Laboratoire de Pharmacognosie et de de Phytothérapie Unité de Formation et de Recherche en Pharmacie Faculté des Sciences de la Santé Université d’Abomey Calavi Cotonou Bénin Laboratoire de Chimie Analytique Pharmaceutique Departement de Pharmacie Université de Liège (ULiège) Liège Belgium

In this work, we evaluated the quality of paracetamol generic tablets while seeking its two main impurities namely 4-para-aminophenol (4-AP) and 4-para-nitrophenol (4-NP) which have nephrotoxic and teratogenic properties. Ninety-four (94) samples were collected at various levels of the medicine supply chain and illegal markets in Benin for quality control tests such as visual inspection, pharmacotechnical tests as mass variation, disintegration test, dissolution test, followed by HPLC UV-Vis identification and assay of paracetamol, 4-AP and 4-NP. The analytes were separated on C18 Lichrocart column (250 mm × 4.0 mm i.d, 5 μm);the mobile phase was MeOH:10 mM ammonium acetate buffer pH 6.8 (35:65) pumped at a flow rate of 1 ml/min. The detection was done at 245 nm. Analysis of our results shows that 77.7% of the samples did not comply with the visual inspection test requirements, 2.1% did not pass the mass variation test, 24.3% of the sample batches didn’t comply with the disintegration test requirements. In addition none of these uncomply batches passed the dissolution test, even if the identification test indicated that all samples contained paracetamol. None contained 4-NP (acceptance limit < 0.05% m/m;BP), while 3 of 94 samples contained 4-AP but within acceptance limit (4-AP < 0.1% m/m;BP). As for the paracetamol assay, 80.9% complied with the specifications of the pharmacopoeias taken as reference (90% - 110%;USP). Further, broader studies should be conducted according to the same rules of good practice for a more comprehensive analysis of the situation. Generally the quality control of paracetamol in most African countries, particularly in Benin, is based on pharmacotechnical tests and paracetamol assay. This work, in addition to the usual tests, showed the importance to search for paracetamol and other drugs’ impurities during their routine quality control.

关键词： Quality Control Substandard Medicines Paracetamol P-Aminophenol P-Nitrophenol Benin

Preliminary Phytochemical Content and Antidiabetic Potential Investigations of <i>Panda oleosa</i>(Pierre) Used in Kisangani Areas

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American Journal of Analytical Chemistry 2017年第9期8卷 564-581页

作者： Frédéric Katemo Muhoya Justin Ntokamunda Kadima Njakarinala Ranarivelo Michel Frédérich Philippe Hubert roland marini djang’eing’a Department of Pharmacy Faculty of Medicine and Pharmacy University of Kisangani Kisangani Democratic Republic of Congo School of Medicine and Pharmacy University of Rwanda Huye Rwanda Laboratory of Pharmacognosy CIRM Department of Pharmacy University of Liege (ULg) Liège Belgium Centre National d’Application des Recherches Pharmaceutiques (CNARP) Ecole Doctorale en Génie des Procédés et des Systèmes Industriels Agricoles et Alimentaires (GPSIAA) University of Antananarivo Antananarivo Madagascar Laboratory of Analytical Chemistry CIRM Department of Pharmacy University of Liege (ULg) Liège Belgium

Panda oleosa Pierre (POP), a tropical plant tree, has been used in traditional medicine in Kisangani city and around to treat various diseases including diabetes and HIV/AIDs. This study aims to evaluate the chemical composition of POP extracts while setting up chromatographic fingerprints for their quality control, and the anti-hyperglycemic potential of trunk bark aqueous extracts of POP. Common chemical reactions were used for identification of main secondary metabolic groups. Thin layer chromatography was used to set up several chromatographic fingerprints of water and alcoholic extracts while evaluating chemical composition. Oral glucose tolerance test served to induce hyperglycemia in a rabbit model. The extracts were given as 25 mg/kg, 50 mg/kg, and 100 mg/kg body weight, 30 minutes before loading animals with glucose 4 g/kg. Blood samples were collected at various times: just before extracts (T-30), before (T0) and after glucose load (T30, T60, T120, and T180). Blood glucose levels were measured with One Touch Glucometer. The identification tests revealed the presence of saponins (3.58%), tannins (5%);alkaloids, quinones, flavonoids, and terpenes sterols could not be formerly detected by the reagents used. Interesting chromatographic spots were observed whose behaviors are of catechic tannin proanthocyanes. The extract significantly reduced glucose levels in dose dependent manner as compared to control and glibenclamide reference groups. The average of mean percentage of reduction in glucose level at T120 with the extract 100 mg/kg was close to that of glibenclamide 0.25 mg/kg (49% and 40.2%). These findings back the traditional use of the plant to treat diabetic patients and constitute a foundation for an extensive study to find a new antidiabetic phythomedicine.

关键词： Panda oleosa Forest Tree Phytochemical Thin Layer Chromatography Phythomedicine Antidiabetic Effect Rabbit

Quality Control of Tramadol in Kisangani: Development, Validation, and Application of a UV-Vis Spectroscopic Method

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American Journal of Analytical Chemistry 2021年第8期12卷 295-309页

作者： Marguerite Borive Amani Jérémie Mbinze Kindenge Emile Tweni Baruti Elodie Nsasi Bakiantima Salomon Batina Agasa Philippe Hubert roland marini djang’eing’a Department of Pharmacy Faculty of Medicine and Pharmacy University of Kisangani Kisangani Democratic Republic of the Congo Laboratory of Drugs Analysis Department of Galenic and Drug Analysis Faculty of Pharmaceutical Sciences University of Kinshasa Kinshasa Democratic Republic of the Congo Department of Internal Medicine Faculty of Medicine and Pharmacy University of Kisangani Kinshasa Democratic Republic of the Congo Laboratory of Analytical Pharmaceutical Chemistry Faculty of Medicine University of Liège Liège Belgium

Context: Substandard and falsified medicines are circulating in low-income countries mostly without any control. We availed a simple and not expensive UV-Vis spectroscopic method to evaluate the quality of tramadol in Kisangani before and during the Covid-19 period. Methods: For the analytical quantitative method, an experimental design was applied to set up the optimal levels of the selected factors, namely, pH of dissolution medium, type of cuvette, and wavelength. Taking into account the capsule pharmaceutical formulation within 80 - 120 μg·mL-1 concentration range, we analyzed 89 tramadol samples from pharmacies and hospitals of the six Kisangani municipalities. Results: pH showed a significant effect on absorbance, whereas quartz cuvette and wavelength did not. A typical 100 μg·mL-1 tramadol solution gave an absorbance of 0.64 at 272 nm. Validation highlighted a matrix effect observed with a 6% bias. A correction factor of 0.9372 allowed to improve the accuracy profile, which were then totally included within the 10% acceptance limits. Quality control revealed that 25 samples out of 89 were not compliant in terms of manufacturing license, registration status in DRC and content as well. Conclusion: This study showed that the strengthening of analytical strategy in Kisangani is a need.

关键词： Tramadol UV-Vis Spectroscopy Method Development Validation Quality Control

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

Substandard/Falsification Antibacterial Agents: A Systematic Review of Liquid Chromatographic and Spectrophotometric Methods for Their Detection

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American Journal of Analytical Chemistry 2019年第8期10卷 348-365页

作者： Pierrot Mwamba Tshilumba Moke Muindu Mutshitshi Kasongo Gaelle Kalonji Mujinga Mbedi Zabakani Joel Kabadi Kasongo Musumba Tshamba Jean-Claude Nkwanga roland marini djang’eing’a Pierre Duez Jean-Baptiste Kalonji Ndoumba Laboratory of Drug Analysis and Galenic University of Lubumbashi Lubumbashi Democratic Republic of Congo Laboratory of Therapeutic Chemistry and Pharmacognosy University of Mons Mons Belgium Departement of Pharmacology and Toxicology University of Lubumbashi Lubumbashi Democratic Republic of Congo Laboratory of Analytical Chemistry CIRM Department of Pharmacy Liege University Liège Belgium

Falsified antibacterial agents continue to pose serious public health problems around the world. They are notably responsible for resistance emergence in the treatment of infectious diseases that can lead to death. The aim of this study was to summarize the literature on the methods developed and validated to detect poor quality antibacterial agents in order to assess the impact of these available methods in the fighting against Counterfeit/substandard medicines. Thus, studies published in the time from January 2000 to July 2017, were accessible via Google Scholar and Pubmed and allowed to analyze 41 papers. The majority (30) of developed and validated methods concerned LC methods, 9 regarded UV/V is spectrophotometry and two studies simultaneously developed both methods. Antibacterial agents belonging to beta-lactams group were the most concerned by the methods developed and validated (39%), followed by quinolones (18%) and macrolides (12%). Regarding active ingredients, amoxicillin (12%) was the most concerned by the development and validation methods. In spite of several available methods to detect substandard drugs, antibacterial agents for which methods were developed and validated were the most concerned by worldwide detected non-conformities. The fight against this scourge should not be only limited by their detection, but it also requires an effective involvement of different actors notably: health authorities, international organizations, pharmaceutical industries etc.

关键词： Counterfeiting/Falsification/Substandard Antibacterial Liquid Chromatography/Spectrophotometry UV/Vis