Article (Scientific journals)
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
Ziemons, Eric; Bourichi, H.; Mantanus, Jérôme et al.
2011In Journal of Pharmaceutical and Biomedical Analysis, 55, p. 1208-1212
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Keywords :
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 center :
C.I.R.M.
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Ziemons, Eric  ;  Université de Liège - ULiège > Département de pharmacie > Département de pharmacie
Bourichi, H.
Mantanus, Jérôme ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Rozet, Eric ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Lebrun, Pierre ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Essassi, E.
Cherrah, Y.
Bouklouze, A.
Hubert, Philippe  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
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
Publication date :
2011
Journal title :
Journal of Pharmaceutical and Biomedical Analysis
ISSN :
0731-7085
eISSN :
1873-264X
Publisher :
Elsevier Science, Oxford, United Kingdom
Volume :
55
Pages :
1208-1212
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
DGTRE - Région wallonne. Direction générale des Technologies, de la Recherche et de l'Énergie [BE]
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