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; Rozet, Eric; Lebrun, Pierre; Essassi, E.; Cherrah, Y.; Bouklouze, A.; Hubert, Philippe

doi:10.1016/j.jpba.2011.02.019

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.

2011 • In Journal of Pharmaceutical and Biomedical Analysis, 55, p. 1208-1212

Peer Reviewed verified by ORBi

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https://hdl.handle.net/2268/84986

DOI
10.1016/j.jpba.2011.02.019

PubMed
21466938

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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/Unit :

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 :

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

Available on ORBi :

since 15 February 2011

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