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See detailTotal Error-Based Validation Including the Experimental Design-Based Robustness Evaluation of a Stability-Indicating Method for the Simultaneous Quantification of Hydrochlorothiazide and Valsartan in Tablet Formulations
ELKARBANE, M; AMOOD AL-KAMARANY, M; BOUCHAFRA, H et al

in Acta Chromatographica (2015), 27(2), 1-20

A gradient reversed phase high-performance liquid chromatography (RPHPLC) method with ultraviolet (UV) detection to analyze hydrochlorothiazide (HCT) and valsartan (VS) simultaneously in a tablet ... [more ▼]

A gradient reversed phase high-performance liquid chromatography (RPHPLC) method with ultraviolet (UV) detection to analyze hydrochlorothiazide (HCT) and valsartan (VS) simultaneously in a tablet formulation during forced degradation studies was developed. This method was validated using a novel approach, namely, the accuracy profile or total errors approach. The robustness of the method was evaluated using a Plackett–Burman design for eight factors. The algorithm of Dong was applied to determine the significant factor effects. The validation results showed that the method is precise (RSD: 1.14% for HCT and 0.43% for VS) and accurate (mean recovery: 99.90% for HCT and 99.98% for VS). On the other hand, the results of the robustness study showed that the type of column was the important factor which affects a number of responses, namely, the asymmetry factor (AF), retention time (RT), and resolution (RS). However, the assay results were not affected; therefore, the method can be considered robust. Finally, the method was applied to study the stability of HCT and VS under forced conditions. Significant results were obtained with basic hydrolysis, oxidation, and thermal stress, while the accelerated and acidic conditions did not affect the stability of HCT or VS. [less ▲]

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See detailRéseau Qualité des Laboratoires de l'ULg - Rapport d'activité Février 2015
Beauvois, Véronique ULiege; Dumont, Fabien ULiege; Hubert, Philippe ULiege et al

Diverse speeche and writing (2015)

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See detailIntroduction à l’incertitude de mesure - Partim 2
Marini Djang'Eing'A, Roland ULiege; Vermaercke, Peter; Hubert, Philippe ULiege

Learning material (2015)

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See detailIntroduction à l’incertitude de mesure - Partim 1
Marini Djang'Eing'A, Roland ULiege; Vermaercke, Peter; Hubert, Philippe ULiege

Learning material (2015)

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See detailAPPUI ANALYTIQUE A LA LUTTE CONTRE LES MEDICAMENTS DE QUALITE INFERIEURE
Mbinze Kindenge, Jérémie; Hubert, Philippe ULiege; Marini Djang'Eing'A, Roland ULiege

Conference (2015, January 27)

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See detailDesign Space for Analytical Methods: Why ? What ? How ?
Rozet, Eric ULiege; Debrus, Benjamin ULiege; Lebrun, Pierre ULiege et al

Conference (2015, January 22)

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See detailFighting Poor Quality Medicines: Develop-ment, Transfer and Validation of Generic HPLC Methods for Analyzing two WHO Recommended Antimalarial Tablets
Mbinze Kindenge, Jérémie; Yemoa, Achille; Lebrun, Pierre ULiege et al

in American Journal of Analytical Chemistry (2015), 6

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 ... [more ▼]

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 devel-oped 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; 10mM) (82.5: 17.5, v/v) at 0.6ml/min through a C18 column (100mm×3.5mm, 3.5 μm) thermostated at 25°C. 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. [less ▲]

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See detailApplication of Total Error Strategy in Validation of Affordable and Accessible UV-Visible Spectrophotometric Methods for Quality Control of Poor Medicines
Mbinze, Kingenge; Nsangu Mpasi, Jean; Maghe, Elza et al

in American Journal of Analytical Chemistry (2015), 6

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 ... [more ▼]

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 2-10µg/mL (for quinine sulfate in tablet), 4-12µg/mL (for quinine bichlorhydrate in oral drop - metronidazole benzaote in oral suspension) and 15-35µg/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. [less ▲]

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See detailQualification de l'équipement
Dispas, Amandine ULiege; Mbinze Kindenge, Jérémie ULiege; Lecomte, Frederic ULiege et al

Learning material (2015)

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See detailFalsification des médicaments en milieu périurbain : triste réalité
Marini Djang'Eing'A, Roland ULiege; Kalenda Tshilombo, Nicodème ULiege; Habyalimana, Védaste ULiege et al

in Bogaert, Jan; Halleux, Jean-Marie (Eds.) Territoires périurbains. Développement, enjeux et prespectives dans les pays du Sud (2015)

Falsifying drugs constitutes a scourge, a danger and a threat to public health. If the situation is already alarming at the global level, what could be expected regarding the peri-urban areas of ... [more ▼]

Falsifying drugs constitutes a scourge, a danger and a threat to public health. If the situation is already alarming at the global level, what could be expected regarding the peri-urban areas of developing countries? In order to better understand the situation in these areas and to improve the consciousness and involvement of the people living in those areas, a study was carried out to evaluate the current status of the pharmaceutical health situation of some cities in Central East and West Africa. The results illustrate the complexity to set up an adequate pharmaceutical system in these areas that seem to escape to the control of the official health authorities. On the other hand, the analytical results carried out by means of generic analytical methods on antibiotic, antimalarial and non-steroidal anti-inflammatory drugs sampled in the peri-urban areas, are revelatory and confirm the sad reality of false drugs in those areas. [less ▲]

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See detailElectroanalytical Method Validation in Pharmaceutical Analysis and Their Applications
OZKAN, Sibel; KAUFFMANN, Jean-Michel; Rozet, Eric ULiege et al

in Ozkan, Sibel Aysil; Kauffmann, Jean-Michel; Zuman, Petr (Eds.) Electroanalysis in Biomedical and Pharmaceutical Sciences : Voltammetry, Amperometry, Biosensors, Applications (2015)

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See detailThorough characterization of a Self-Emulsifying Drug Delivery System with Raman hyperspectral imaging: A case study.
Sacre, Pierre-Yves ULiege; Netchacovitch, Lauranne ULiege; De Bleye, Charlotte ULiege et al

in International Journal of Pharmaceutics (2015), 484

Newly developed drugs often have poor bioavailability due to their poor water solubility (BCS class 2 drugs). It is therefore necessary to develop new strategies to enhance their solubility and their ... [more ▼]

Newly developed drugs often have poor bioavailability due to their poor water solubility (BCS class 2 drugs). It is therefore necessary to develop new strategies to enhance their solubility and their activity, among which, Self-Emulsifying Drug Delivery System (SEDDS). The efficacy of the drugs contained in these preparations is mainly affected by the solid state and the particle size of the active pharmaceutical ingredient (API). However, it is quite complex, long and expensive to characterize these parameters with classical techniques such as X-Ray powder diffraction, differential scanning calorimetry or hot stage microscopy. The present article presents, through a case study, the advantages of the Raman hyperspectral imaging in the characterization of such formulations. Indeed, Raman chemical imaging may fully characterize SEDDS with single equipment and operator in a non-destructive way allowing the follow-up of the formulation during stability studies. Raman imaging is therefore a tool of choice in the PAT framework since it increases the knowledge of the formulation and the process. A quantitative multivariate method using Raman hyperspectral imaging to assay the API in the lipid based formulation has been developed and fully validated following the “total error” approach. [less ▲]

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See detailTowards a full integration of optimization and validation phases: An Analytical-Quality-by-Design approach
Hubert, Cédric ULiege; Houari, Sabah ULiege; Rozet, Eric ULiege et al

in Journal of Chromatography. A (2015)

When using an analytical method, defining an Analytical Target Profile (ATP) focused on quantitative performance represents a key input, and this will drive the method development process. In this context ... [more ▼]

When using an analytical method, defining an Analytical Target Profile (ATP) focused on quantitative performance represents a key input, and this will drive the method development process. In this context, two case studies were selected in order to demonstrate the potential of a Quality-by-Design (QbD) strategy when applied to two specific phases of the method lifecycle: the pre-validation study and the validation step. The first case study focused on the improvement of a Liquid Chromatography (LC) coupled to Mass Spectrometry (MS) stability-indicating method by the means of the QbD concept. The Design of Experiments (DoE) conducted during the optimization step (i.e. determination of the qualitative Design Space (DS)) was performed a posteriori. Additional experiments were performed in order to simultaneously conduct the pre-validation study to assist in defining the DoE to be conducted during the formal validation step. This predicted protocol was compared to the one used during the formal validation. A second case study based on the LC/MS-MS determination of glucosamine and galactosamine in human plasma was considered in order to illustrate an innovative strategy allowing the QbD methodology to be incorporated during the validation phase. An operational space, defined by the qualitative DS, was considered during the validation process rather than a specific set of working conditions as conventionally performed. Results of all the validation parameters conventionally studied were compared to those obtained with this innovative approach for glucosamine and galactosamine. Using this strategy, qualitative and quantitative information were obtained. Consequently, an analyst using this approach would be able to select with great confidence several working conditions within the operational space rather than a given condition for the routine use of the method. This innovative strategy combines both a learning process and a thorough assessment of the risk involved. [less ▲]

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