Audits de qualités des fournisseurs de produits pharmaceutiques: Aspects théoriques et pratiques

Learning material (2010)

Vidéo du cours intitulé "Audits de qualités des fournisseurs de produits pharmaceutiques: Aspects théoriques et pratiques".

Liquid chromatographic analysis of local anesthetics in human plasma after sample preparation by on-line dialysis. Optimization by use of experimental design

in Chromatographia (2001), 53(11-12), 678-686

A fully automated method involving dialysis, clean-up and enrichment of the dialysate on a pre-column packed with a strong cation-exchange phase, and subsequent liquid chromatographic (LC) analysis with ... [more ▼]

A fully automated method involving dialysis, clean-up and enrichment of the dialysate on a pre-column packed with a strong cation-exchange phase, and subsequent liquid chromatographic (LC) analysis with UV detection at 220 nm has been developed for the determination of local anesthetics (prilocaine, mepivacaine, and bupivacaine) in human plasma. All sample-handling operations were executed automatically by means of an Asted XI system. To identify the most important conditions affecting analyte recovery from the dialysis and trace-enrichment processes, a seven-factor D-optimal design with 16 experimental points was elaborated as a screening test A four-factor D-optimal design with 24 experimental points was then used to predict and optimize analyte recovery. Derringer's desirability function was also used to deduce optimum conditions for analyte recovery and dialysis time within the experimental domain. Finally, the method developed was validated. Mean recoveries were approximately 72% for bupivacaine and approximately 67% for mepivacaine and prilocaine. The limits of quantification were 28 ng mL(-1) for bupivacaine and 25 ng mL(-1) for mepivacaine and prilocaine. [less ▲]

Separation of non-steroidal anti-inflammatory drugs by capillary electrophoresis using non-aqueous electrolyte.

in Biomedical Chromatography : BMC (2000), 14(1), 12-3

Separation of non-steroidal anti-inflammatory drugs by capillary electrophoresis using non-aqueous electrolyte.

Method development strategies for enantiomeric separations by capillary electrophoresis using charged and neutral cyclodextrin derivatives as chiral selectors

Conference (1999)

Design of dual cyclodextrin systems in capillary electrophoresis for selectivity optimisation in enantiomeric separations

Conference (1999)

Elimination of adsorption effects in the analysis of pharmaceutical formulations by capillary electrophoresis

Poster (1999)

Determination of copper, iron and zinc in pharmaceutical formulations by capillary electrophoresis

Poster (1999)

Selectivity improvement in the capillary electrophoretic enantioseparation of uncharged compounds by use of mixtures of charged and neutral cyclodextrins

Poster (1998)

Determination of Six Water-Soluble Vitamins in a Pharmaceutical Formulation by Capillary Electrophoresis

in Journal of Pharmaceutical & Biomedical Analysis (1997), 15(8), 1113-23

A method was developed for the quantitative analysis of six water-soluble vitamins (thiamine, nicotinamide, riboflavine, pyridoxine, ascorbic acid and pantothenic acid) in a pharmaceutical formulation ... [more ▼]

A method was developed for the quantitative analysis of six water-soluble vitamins (thiamine, nicotinamide, riboflavine, pyridoxine, ascorbic acid and pantothenic acid) in a pharmaceutical formulation, using free solution capillary zone electrophoresis (CZE) in uncoated fused silica capillaries and UV detection. The influence of different parameters, such as the nature of the buffer anionic component and buffer concentration on the CZE separation of vitamins was investigated using four vitamins of the B group as model compounds. A good compromise between resolution, analysis time and analyte stability was obtained by use of a 50 mM borax buffer of pH 8.5. This CZE method was found to be very useful for the separation of more complex samples, a mixture of ten water-soluble vitamins being completely resolved in about 10 min. However, cyanocobalamine could not be separated from nicotinamide in this CZE system, the two compounds being in uncharged form at the pH used. These two compounds could easily be resolved by micellar electrokinetic chromatography (MEKC), the anionic surfactant dodecylsulfate being added to the running buffer at 25 mM concentration. In the pharmaceutical formulation, some excipients were found to be adsorbed to the capillary surface, giving rise to a progressive decrease of the electroosmotic flow and consequently to a simultaneous increase of analyte migration times. A capillary wash with sodium hydroxide had to be made between successive runs in order to minimize these effects. Good results with respect to linearity, precision and accuracy were obtained in the concentration range studied for the six vitamins, using nicotinic acid as internal standard. [less ▲]

Quantitative analysis of six water-soluble vitamins in a pharmaceutical formulation by capillary electrophoresis

Poster (1997)