title: A simple calibration approach based on film-casting for confocal Raman microscopy to support the development of a hot-melt extrusion process.
abstract: When developing a new formulation, the development, calibration and validation steps of analytical methods based on vibrational spectroscopy are time-consuming. For each new formulation, real samples must be produced and a "reference method" must be used in order to determine the Active Pharmaceutical Ingredient (API) content of each sample. To circumvent this issue, the paper presents a simple approach based on the film-casting technique used as a calibration tool in the framework of hot-melt extrusion process. Confocal Raman microscopic method was successfully validated for the determination of itraconazole content in film-casting samples. Then, hot-melt extrusion was carried out to produce real samples in order to confront the results obtained with confocal Raman microscopy and Ultra High Performance Liquid Chromatography (UHPLC). The agreement between both methods was demonstrated using a comparison study based on the Bland and Altman's plot.
authors.affiliation: University of Liege (ULg), CIRM, Department of Pharmacy, Laboratory of Analytical Chemistry, CHU, Quartier Hôpital, Avenue Hippocrate 15, B-4000 Liege, Belgium. Electronic address: lnetchacovitch@ulg.ac.be.
authors.forename: L
authors.initials: L
authors.lastname: Netchacovitch
authors.affiliation: University of Liege (ULg), CIRM, Department of Pharmacy, Laboratory of Pharmaceutical Technology and Biopharmacy, CHU, Quartier Hôpital, Avenue Hippocrate 15, B-4000 Liege, Belgium.
authors.forename: J
authors.initials: J
authors.lastname: Thiry
authors.affiliation: University of Liege (ULg), CIRM, Department of Pharmacy, Laboratory of Analytical Chemistry, CHU, Quartier Hôpital, Avenue Hippocrate 15, B-4000 Liege, Belgium.
authors.forename: C
authors.initials: C
authors.lastname: De Bleye
authors.affiliation: University of Liege (ULg), CIRM, Department of Pharmacy, Laboratory of Analytical Chemistry, CHU, Quartier Hôpital, Avenue Hippocrate 15, B-4000 Liege, Belgium.
authors.forename: E
authors.initials: E
authors.lastname: Dumont
authors.affiliation: University of Liege (ULg), CIRM, Department of Pharmacy, Laboratory of Analytical Chemistry, CHU, Quartier Hôpital, Avenue Hippocrate 15, B-4000 Liege, Belgium.
authors.forename: A
authors.initials: A
authors.lastname: Dispas
authors.affiliation: University of Liege (ULg), CIRM, Department of Pharmacy, Laboratory of Analytical Chemistry, CHU, Quartier Hôpital, Avenue Hippocrate 15, B-4000 Liege, Belgium.
authors.forename: C
authors.initials: C
authors.lastname: Hubert
authors.affiliation: University of Liege (ULg), CIRM, Department of Pharmacy, Laboratory of Pharmaceutical Technology and Biopharmacy, CHU, Quartier Hôpital, Avenue Hippocrate 15, B-4000 Liege, Belgium.
authors.forename: F
authors.initials: F
authors.lastname: Krier
authors.affiliation: University of Liege (ULg), CIRM, Department of Pharmacy, Laboratory of Analytical Chemistry, CHU, Quartier Hôpital, Avenue Hippocrate 15, B-4000 Liege, Belgium.
authors.forename: P-Y
authors.initials: PY
authors.lastname: Sacré
authors.affiliation: University of Liege (ULg), CIRM, Department of Pharmacy, Laboratory of Pharmaceutical Technology and Biopharmacy, CHU, Quartier Hôpital, Avenue Hippocrate 15, B-4000 Liege, Belgium.
authors.forename: B
authors.initials: B
authors.lastname: Evrard
authors.affiliation: University of Liege (ULg), CIRM, Department of Pharmacy, Laboratory of Analytical Chemistry, CHU, Quartier Hôpital, Avenue Hippocrate 15, B-4000 Liege, Belgium.
authors.forename: Ph
authors.initials: P
authors.lastname: Hubert
authors.affiliation: University of Liege (ULg), CIRM, Department of Pharmacy, Laboratory of Analytical Chemistry, CHU, Quartier Hôpital, Avenue Hippocrate 15, B-4000 Liege, Belgium.
authors.forename: E
authors.initials: E
authors.lastname: Ziemons
keywords: Accuracy profile; Confocal Raman microscopy; Film-casting technique; Hot-melt extrusion; Ultra High Performance Liquid Chromatography