Rapid quantification of 2-hydroxypropyl-β-cyclodextrin in liquid pharmaceutical formulations by 1H nuclear magnetic resonance spectroscopy

European Journal of Pharmaceutical Sciences

Volumn 73, Issue , 2015, Pages 20-28

  Dufour, Gilles ^a   Evrard, Brigitte ^a   De Tullio, Pascal ^a  

^a UNIVERSITY OF LIÈGE   (Belgium)

Author keywords

1HNMR; Cyclodextrins; Pharmaceutical solutions; Quality assessment; Quantification

Indexed keywords

2 HYDROXYPROPYL BETA CYCLODEXTRIN; 2-HYDROXYPROPYL-BETA-CYCLODEXTRIN; BETA CYCLODEXTRIN DERIVATIVE; BUDESONIDE; DRUG ADMINISTRATION; DRUG ANALYSIS; EXCIPIENT; EYE DROPS; INDOMETACIN; ITRACONAZOLE;

ANALYTIC METHOD; AQUEOUS SOLUTION; ARTICLE; CALIBRATION; CHEMICAL ANALYSIS; CHEMICAL MODIFICATION; DRUG FORMULATION; DRUG MIXTURE; DRUG RESPONSE; DRUG SOLUTION; LIMIT OF DETECTION; LIMIT OF QUANTITATION; MEDICINAL CHEMISTRY; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; PHASE SEPARATION; PRIORITY JOURNAL; PROTON NUCLEAR MAGNETIC RESONANCE; QUALITY CONTROL; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; SEPARATION TECHNIQUE; VALIDATION PROCESS;

ADMINISTRATION AND DOSAGE; ANALYSIS; BETA-CYCLODEXTRINS; BUDESONIDE; CALIBRATION; CHEMISTRY, PHARMACEUTICAL; EXCIPIENTS; INDOMETHACIN; ITRACONAZOLE; LIMIT OF DETECTION; MAGNETIC RESONANCE SPECTROSCOPY; REPRODUCIBILITY OF RESULTS;

EID: 84964247611     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2015.03.005     Document Type: Article

References (31)

1. M. Agueros, M.A. Campanero, and J.M. lrache Simultaneous quantification of different cyclodextrins and Gantrez by HPLC with evaporative light scattering detection J. Pharm. Biomed. Anal. 39 2005 495 502
2. R. Arun Cyclodextrins as drug carrier molecule: a review Sci. Pharm. 76 2008 567 598
3. P. Bertholet, M. Gueders, G. Dive, A. Albert, V. Barillaro, B. Perly, D. Cataldo, G. Piel, L. Delattre, and B. Evrard The effect of cyclodextrins on the aqueous solubility of a new MMP inhibitor: phase solubility, 1H-NMR spectroscopy and molecular modeling studies, preparation and stability study of nebulizable solutions J. Pharm. Pharm. Sci. 8 2005 164 175
4. B. Boulanger, E. Rozet, F. Moonen, S. Rudaz, and P. Hubert A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation J. Chromatogr. B, Anal. Technol. Biomed. Life Sci. 877 2009 2235 2243
5. M.E. Brewster, and T. Loftsson Cyclodextrins as pharmaceutical solubilizers Adv. Drug Deliv. Rev. 59 2007 645 666
6. F. Camargo, R.P. Erickson, W.S. Garver, G.S. Hossain, P.N. Carbone, R.A. Heidenreich, and J. Blanchard Cyclodextrins in the treatment of a mouse model of Niemann-Pick C disease Life Sci. 70 2001 131 142
7. R.L. Carrier, L.A. Miller, and I. Ahmed The utility of cyclodextrins for enhancing oral bioavailability J. Control. Release: Off. J. Control. Release Soc. 123 2007 78 99
8. E.M.M. Del Valle Cyclodextrins and their uses: a review Process Biochem. 39 2004 1033 1046
9. W. Hammes, C. Bourscheidt, U. Büchsler, G. Stodt, and H. Bökens Quantitative determination of a-cyclodextrin in human plasma by liquid chromatography/positive ion electrospray mass spectrometry J. Mass Spectrom. 35 2000 378 384
10. K. Higashi, S. Ideura, H. Waraya, K. Moribe, and K. Yamamoto Incorporation of salicylic acid molecules into the intermolecular spaces of γ-cyclodextrin-polypseudorotaxane Cryst. Growth Des. 9 2009 4243 4246
11. U. Holzgrabe, R. Deubner, C. Schollmayer, and B. Waibel Quantitative NMR spectroscopy - applications in drug analysis J. Pharm. Biomed. Anal. 38 2005 806 812
12. P. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, and L. Valat Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal - Part I J. Pharm. Biomed. Anal. 36 2004 579 586
13. R.S. Hui Jiang, Hideji Fujiwara, Marc De Meulder, Ronald de Vries, Yong Gong, Mark Kao, Nicole M. Yanjanin, Nuria Carillo-Carasco, Xin Xu, Elizabeth, M.W. Ottinger, S. Daniel, Ory, and Xuntian Jiang Development and validation of sensitive LC-MS/MS assays for quantification of HP-β-CD in human plasma and CSF J. Lipid Res. 55 2014
14. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, T.Q.R.V.o.A.P.T.a.M., Geneva, 2005. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, Geneva.
15. A. Lis-Cieplak, J. Sitkowski, and W. Kolodziejski Comparative proton nuclear magnetic resonance studies of amantadine complexes formed in aqueous solutions with three major cyclodextrins J. Pharm. Sci. 103 2014 274 282
16. T. Loftsson, and M.E. Brewster Pharmaceutical applications of cyclodextrins: basic science and product development J. Pharm. Pharmacol. 62 2010 1607 1621
17. M. Malet-Martino, and U. Holzgrabe NMR techniques in biomedical and pharmaceutical analysis J. Pharm. Biomed. Anal. 55 2011 1 15
18. L. Matilainen, T. Toropainen, H. Vihola, J. Hirvonen, T. Jarvinen, P. Jarho, and K. Jarvinen In vitro toxicity and permeation of cyclodextrins in Calu-3 cells J. Control. Release: Off. J. Control. Release Soc. 126 2008 10 16
19. M. Nitalikar, D. Sakarkar, and P. Jain The cyclodextrins: a review J. Curr. Pharm. Res. 10 2012 01 06
20. R. Norman, and H. Smith Applied Regression Analysis third ed. 1998 Wiley
21. N. Ono, Y. Miyamoto, T. Ishiguro, K. Motoyama, F. Hirayama, D. Iohara, H. Seo, S. Tsuruta, H. Arima, and K. Uekama Reduction of bitterness of antihistaminic drugs by complexation with beta-cyclodextrins J. Pharm. Sci. 100 2011 1935 1943
22. G.F. Pauli, T. Godecke, B.U. Jaki, and D.C. Lankin Quantitative 1H NMR. Development and potential of an analytical method: an update J. Nat. Prod. 75 2012 834 851
23. E. Rozet, A. Ceccato, C. Hubert, E. Ziemons, R. Oprean, S. Rudaz, B. Boulanger, and P. Hubert Using tolerance intervals in pre-study validation of analytical methods to predict in-study results J. Chromatogr. A 1158 2007 111 125
24. E. Rozet, R.D. Marini, E. Ziemons, B. Boulanger, and P. Hubert Advances in validation, risk and uncertainty assessment of bioanalytical methods J. Pharm. Biomed. Anal. 55 2011 848 858
25. H.-J. Schneider, F. Hacket, and V. Rüdiger NMR studies of cyclodextrins and cyclodextrin complexes Chem. Rev. 98 1998 1755 1785
26. V.J. Stella, and Q. He Cyclodextrins Toxicol. Pathol. 36 2008 30 42
27. J. Szejtli, and L. Szente Elimination of bitter, disgusting tastes of drugs and foods by cyclodextrins Eur. J. Pharm. Biopharm.: Off. J. Arbeitsgemeinschaft Pharm. Verfahrenstechnik 61 2005 115 125
28. J. Szeman, A. Gerloczy, K. Csabai, J. Szejtli, G.L. Kis, P. Su, R.Y. Chau, and A. Jacober High-performance liquid chromatographic determination of 2-hydroxypropyl-g-cyclodextrin in different biological fluids based on cyclodextrin enhanced fluorescence J. Chromatogr. B 774 2002 157 164
29. F.G. Vogt, and M. Strohmeier 2D solid-state NMR analysis of inclusion in drug-cyclodextrin complexes Mol. Pharm. 9 2012 3357 3374
30. C.M. Vozone, and H.M. Cabral Marques Complexation of budesonide in cyclodextrins and particle aerodynamic characterization of the complex solid form for dry powder inhalation J. Incl. Phenom. Macrocycl. Chem. 44 2002 5
31. B. Yang, J. Lin, Y. Chen, and Y. Liu Artemether/hydroxypropyl-beta-cyclodextrin host-guest system: characterization, phase-solubility and inclusion mode Bioorg. Med. Chem. 17 2009 6311 6317