DEMARCHE STATISTIQUE DE LA VALIDATION ANALYTIQUE DANS LE DOMAINE PHARMACEUTIQUE (Méthodologie et exemple pratique)

Cet article a été élaboré dans le but d’aider les industriels du médicament, les organismes de contrôle nationaux à valider leurs procédures d’analyse. Le protocole expérimental appliqué dans ce document est basé sur une méthodologie commune inspirée de la stratégie des guidelines ICH (International Conference on Harmonization ) et celles de la SFSTP (Société Française des Sciences Techniques et Pharmaceutiques pour mieux encore optimiser le nombre d’essais à réaliser et satisfaire à l’étude des critères de validation.La démarche statistique qui sera appliquée aux données brutes est décrite. Et afin de mieux appréhender l’exploitation statistique des données brutes un exemple d’application est traité

Rapid extraction and detection of ellagic acid in plant samples using a selective magnetic molecularly imprinted polymer coupled to a fluorescence method

A remarkable growth was noticed in the development of molecularly imprinted polymers (MIPs), which have used as efficient synthetic antibodies that contain selective cavities to the target molecule. Hereunder, a novel strategy using MIP as a sorbent in solid-phase extraction was coupled to a fluorescence method for ellagic acid (EA) purification and immediate detection. The synthesis of magnetic-MIP (MMIP) using a rapid and green ultrasound technology was assessed by central composite design to determine the optimal polymerization conditions for a high-imprinting polymer. The MMIP was characterized by Fourier transform infrared spectroscopy, X-ray diffraction, thermogravimetric analysis, and scanning/transmission electron microscopy, which accurately confirmed the functional, magnetic, and morphological features of MMIP. The prepared MMIP was demonstrated to be selective for EA compared to many similar phenols. The spectrofluorometric method showed a linear range from 0.05 to 2 μg·mL−1 of EA, and the limits of detection (LOD) and quantification (LOQ) were 0.005 and 0.02 μg·mL−1, respectively. Besides, the novel proposed smartphone method using the ultraviolet lamp as the excitation source presented a linear range from 0.2 to 4 μg·mL−1, a LOQ of 0.2 μg·mL−1, and a LOD of 0.07 μg.mL−1. The proposed strategy revealed high efficiency in the extraction and detection of EA in grape, redberry, and green tea. Effectively, the calculated recoveries were ranging from 80 to 102% with low values of relative standard deviation ([removed]10 página

Electroanalysis of drugs at carbon paste electrodes modified by amphiphiles

info:eu-repo/semantics/nonPublishe

Application of Statistical Experimental Design and Surface Plot Technique to Optimize Oxygenated Apatite Synthesis

This work deals with oxygenated apatite synthesis from calcium chloride and phosphoric acid using a wet precipitation method. An experimental design is applied to precise the influence of the synthesis parameters (pH of the reaction medium, atomic ratio Ca/P of the reagents, concentration of the calcium solution (Ca2+), temperature of the reaction medium (T), and duration of the reaction (D)) on the chemical composition (Ca/P molar ratio, % O2, and % O22−). An empirical model was developed and validated by applying the ANOVA analysis incorporating the interaction effects of all parameters and optimized using the response surface methodology. A reproducible synthesis of more oxygenated apatite with speed of dissolution adaptable to that of the osseous neoformation and allowing a progressive diffusion of oxygenated species (Ca/P = 1.575) is attained

A Microdialysis probe coupled with a miniaturized thermal glucose sensor for in vivo monitoring

A miniaturized thermal flow injection analysis biosensor has been coupled with a microdialysis probe for continuous subcutaneous glucose monitoring. Thermal biosensors are based on the principle of measuring the heat evolved during enzyme catalysed reactions. The system presented here consists of a miniaturized thermal biosensor with a small column containing coimmibolized glucose oxidase and catalase. The analysis buffer passes through the column at a flow rate of 60uL/min via an 1uL sample loop which is connected to a microdialysis probe. © 1995, Taylor & Francis Group, LLC. All rights reserved.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Determination of cisplatin in human plasma by HPLC with a glassy carbon based wall jet amperometric detector

info:eu-repo/semantics/publishe

Electrochemical study of cycloserine and its degradation products

info:eu-repo/semantics/nonPublishe

Characterization of antiseptic apatite powders prepared at biomimetics temperature and pH

Antiseptic apatite-based calcium phosphates were prepared as the single-phase powders. Phosphocalcic oxygenated apatites were synthesized from calcium salts and orthophosphate dissolved in oxygenated water solution at 30%, under the biomimetic conditions of 37 °C and pH 7.4. The characterization and chemical analysis of the synthesized biomimetic apatite powders were performed by scanning electron microscopy (SEM), powder X ray diffraction (XRD), Fourier-transformed infrared spectroscopy (FT-IR) and chemical analysis. The obtained materials are a calcium deficient apatites with different morphologies