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
[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]
Polymorphism, European Pharmacopoeia, sixth ed., Strasbourg, 2010, p. 649.
Grant D.J.W., Byrn S.R. A timely re-examination of drug polymorphism in pharmaceutical development and regulation. Adv. Drug Deliv. Rev. 2004, 56:237-239.
Raw A.S., Furness M.S., Gill D.S., Adams R.C., Holcombe F.O., Yu L.X. Regulatory considerations of pharmaceutical solid polymorphism in abbreviated new drug applications (ANDAs). Adv. Drug Deliv. Rev. 2004, 56:397-414.
International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceutical for human use, Topic Q6A: Specifications: Test Procedures and acceptance criteria for new drug substances and new drug products, Geneva, 1999.
Snider D.A., Addicks W., Owens W. Polymorphism in generic drug product development. Adv. Drug Deliv. Rev. 2004, 56:391-395.
Musiol R., Jampilek J., Buchta V., Silva L., Niedbala H., Podeszwa B., Palka A., Majerz-Maniecka K., Oleksyn B., Polanski J. Antifungal properties of new series of quinoline derivatives. Bioorgan. Med. Chem. 2006, 14:3592-3598.
Sun Q.Y., Zhang W.N., Xu J.M., Cao Y.B., Wu Q.Y., Zhang D.Z., Liu C.M., Yu S.C., Jiang Y.Y. Synthesis and evaluation of novel 1-(1H-1 2,4-triazol-1-yl)-2-(2,4-difluorophenyl)-3-[(4-substitutedphenyl)- piperazin-1-yl]-propan-2-ols as antifungal agents. Eur. J. Med. Chem. 2007, 42:1151-1157.
Zervos M., Meunier F. Fluconazole (Diflucan®): a review. Int. J. Antimicrob. Agents 1993, 3:147-170.
Sheehan D.J., Hitchcock C.A., Sibley C.M. Current and emerging azole antifungal agents. Clin. Microbiol. Rev. 1999, 12:40-79.
Dash A.K., Elmquist W.F. Fluconazole. Analytical Profiles of Drug Substances and Excipients 2002, 67-113. Academic Press, Milford. H.G. Brittain (Ed.).
Bourichi H., Brik Y., Essassi E., Bouklouze A., Cherrah Y. Solid-state characterization of fluconazole. STP Pharma Pratiques 2007, 17:49-57.
Gu X.J., Jiang W. Characterization of polymorphic forms of fluconazole using Fourier-transform Raman spectroscopy. J. Pharm. Sci. U.S. 1995, 84:1438-1441.
Caira M.R., Alkhamis K.A., Obaidat R.M. Preparation and crystal characterisation of a polymorph a monohydrate and an ethyl acetate solvate of the antifungal fluconazole. J. Pharm. Sci. U.S. 2004, 93:601-611.
Desai S.R., Shaikh M.M., Dharwadkar S.R. Thermoanalytical study of polymorphic transformation in fluconazole drug. Thermochim. Acta 2003, 399:81-89.
Cyr T.D., Dawson B.A., Neville G.A., Shurvell H.F. Spectral characterization of fluconazole. J. Pharm. Biomed. Anal. 1996, 14:247-255.
Bourichi H., Brik Y., Essassi E., Bouklouze A., Cherrah Y. Quality control of impurities in fluconazole active raw material by HPLC-UV. STP Pharma Pratiques 2008, 18:285-291.
Bodson C., Rozet E., Ziemons E., Evrard B., Hubert Ph., Delattre L. Validation of manufacturing process of Diltiazem HCl tablets by NIR spectrophotometry (NIRS). J. Pharma. Biomed. Anal. 2007, 45:356-361. http://hdl.handle.net/2268/1642.
Bouabidi A., Rozet E., Fillet M., Ziemons E., Chapuzet E., Mertens B., Klinkenberg R., Ceccato A., Talbi M., streel B., Bouklouze A., Boulanger B., Hubert Ph. Critical analysis of several analytical method validation strategies in the framework of the fit for purpose concept. J. Chromatogr. A 2010, 1217:3180-3192. http://hdl.handle.net/2268/29471.
Mantanus J., Ziemons E., Lebrun P., Rozet E., Klinkerberg R., Streel B., Evrard B., Hubert Ph. Moisture content détermination of pharmaceutical pellets by near infrared spectroscopy: method development and validation. Anal. Chim. Acta 2009, 642:186-192. http://dl.handle.net/2268/18780.
Bland J.M., Altman D.G. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986, 1:307-310.
Rinnan A., van den Berg F., Balling Engelsen S. Review of the most common pre-processing techniques for near-infrared spectra. Trends Anal. Chem. 2009, 10:1201-1222.