ORBi: Ziemons Eric - Determination of binary polymorphic mixtures of fluconazole using near infrared spectroscopy and X-ray powder diffraction: A comparative study based on the pre-validation stage results

Reference : Determination of binary polymorphic mixtures of fluconazole using near infrared spectros...


	Document type :	Scientific journals : Article
	Discipline(s) :	Human health sciences : Pharmacy, pharmacology & toxicology
	To cite this reference:	http://hdl.handle.net/2268/84986

Title :	Determination of binary polymorphic mixtures of fluconazole using near infrared spectroscopy and X-ray powder diffraction: A comparative study based on the pre-validation stage results
Language :	English
Author, co-author :	Ziemons, Eric [Université de Liège - ULg > Département de pharmacie > Département de pharmacie >]
	Bourichi, H. [ > > ]
	Mantanus, Jérôme [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
	Rozet, Eric [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
	Lebrun, Pierre [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
	Essassi, E. [ > > ]
	Cherrah, Y. [ > > ]
	Bouklouze, A. [ > > ]
	Hubert, Philippe [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Publication date :	2011
Journal title :	Journal of Pharmaceutical & Biomedical Analysis
Publisher :	Elsevier Science
Volume :	55
Pages :	1208-1212
Audience :	International
ISSN :	0731-7085
City :	Oxford
Country :	United Kingdom
Keywords :	[en] Fluconazole ; Polymorphism ; Near infrared spectroscopy ; X-ray powder diffraction ; Accuracy profile ; Pre-validation step
Abstract :	[en] The aim of the present study was to develop near infrared (NIR) and X-ray powder diffraction methods (XRPD) able to determine pure crystalline form II of fluconazole in a binary polymorphic mixtures containing form II and III. In order to give a first performance estimation of both methods, these latters were pre-validated using accuracy profiles, a statistical approach based on β-expectation tolerance intervals. Both methods showed a good trueness, precision and accuracy and their β-expectation tolerance intervals were fully included within the acceptance limits. The comparative study was carried out using statistical analysis based on the work of Bland and Altman. A good agreement between the two methods was demonstrated indicating the interchangeability of NIR method with XRPD method.
Research units :	C.I.R.M.
Funders :	Région wallonne : Direction générale des Technologies, de la Recherche et de l'Energie - DGTRE
Target :	Researchers ; Professionals
Permalink :	http://hdl.handle.net/2268/84986

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