Robustness testing of a chiral NACE method for R-timolol determination in S-timolol maleate and uncertainty assessment from quantitative data

Journal of Pharmaceutical and Biomedical Analysis

Volumn 44, Issue 3 SPEC. ISS., 2007, Pages 640-651

  Marini, R D ^a   Rozet, E ^a   Heyden, Y Vander ^b   Ziemons, E ^a   Boulanger, B ^c   Bouklouze, A ^d   Servais, A C ^a   Fillet, M ^a   Crommen, J ^a   Hubert, Ph ^a  

^a UNIVERSITY OF LIÈGE   (Belgium)

^b VRIJE UNIVERSITEIT BRUSSEL   (Belgium)

^c Eli Lilly Benelux   (Belgium)

^d MOHAMMED V UNIVERSITY   (Morocco)

Author keywords

Nonaqueous capillary electrophoresis; R timolol content; Robustness testing; Uncertainty assessment

Indexed keywords

HEPTAKIS(2,6 O DIMETHYL) BETA CYCLODEXTRIN; PYRIDOXINE; TIMOLOL; TIMOLOL MALEATE;

ARTICLE; CAPILLARY ELECTROPHORESIS; CHIRAL CHROMATOGRAPHY; DRUG DETERMINATION; ELECTROPHORESIS; MIGRATION; OPTICAL RESOLUTION; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SEPARATION TECHNIQUE;

EID: 34447274803     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2006.08.018     Document Type: Article

References (37)

1. ICH Harmonised Tripartite Guideline prepared within the Third International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), Text on Validation of Analytical Procedures: Methodology, 1994.
2. Vander Heyden Y., Nijhuis A., Smeyers-Verbecke J., Vandeginste B.G.M., and Massart D.L. J. Pharm. Biomed. Anal. 24 (2001) 723-753
3. Jimidar M., Van Ael W., De Smet M., and Cockaerts P. LC GC 15 (2002) 230-242
4. United States Pharmacopeia. National Formulary 18. 24th ed. (2002), United States Pharmacopeial Convention, Rockville, USA
5. Hund E., Vander Heyden Y., Haustein M., Massart D.L., and Smeyers-Verbeke J. J. Chromatogr. A 874 (2000) 167-185
6. Hund E., Vander Heyden Y., Haustein M., Massart D.L., and Smeyers-Verbeke J. Anal. Chim. Acta 404 (2000) 257-271
7. Mayer B.X. J. Chromatogr. A 907 (2001) 21-37
8. ICH Harmonised Tripartite Guideline, Topic Q2A, Validation of Analytical Methods: Definition and Terminology, CPMP/ICH/381/95.
9. Marini R.D., Servais A.-C., Rozet E., Chiap P., Boulanger B., Rudaz S., Crommen J., Hubert Ph., and Fillet M. NACE method for the enantiomeric purity determination of S-timolol using HDMS-β-CD: validation using the accuracy profile strategy and estimation of uncertainty. J. Chromatogr. A 1120 (2006) 102-111
10. Frishman H.W., Furberg D.C., and Friedwald T.W. N. Engl. J. Med. 310 (1984) 830-837
11. The International Collaborative Study Group. N. Engl. J. Med. 310 (1984) 9-15
12. Dickstein K., Hapnes R., and Aarsland T. Am. J. Ophtalmol. 132 (2001) 626-631
13. Mayer B.X., Müller M., and Altria K.D. LC-GC Europe 14 (2001) 19-26
14. Altria K.D., Harden R.C., Hart M., Hevizi J., Hailey P.A., Makwana J.V., and Portsmouth M.J. J. Chromatogr. 641 (1993) 147-153
15. Marini R.D., Groom C., Doucet F.R., Hawari J., Bitar Y., Holzgrabe U., Gotti R., Schappler J., Rudaz S., Veuthey J.-L., Mol R., Somsen G.W., De Jong G.J., Thanh Ha Ph.Th., Zhang J., Van Schepdael A., Hoogmartens J., Briône W., Ceccato A., Boulanger B., Mangelings D., Vander Heyden Y., Van Ael W., Jimidar I., Pedrini M., Servais A.-C., Fillet M., Crommen J., Rozet E., and Hubert Ph. Interlaboratory study of a NACE method for the determination of R-timolol content in S-timolol maleate: assessment of uncertainty. Electrophoresis 27 (2006) 2386-2399
16. Mopper B., and Sciacchitano C.J. J. Cap. Electrophor. 4 (1997) 73-76
17. Eurachem/Citac Guide. Quantifying the Uncertainty in Analytical Measurement. second ed. (2000), Eurachem Secretariat, Budapest, Hungary
18. International Organization for Standardisation. International Vocabulary of Basic and General Terms in Metrology. second ed. (1993), International Organization for Standardisation, Geneva
19. VAM, Project 3.2.1. Development and harmonisation of Measurements Uncertainty Principles, Part (d), LGC/VAM/1998/088, January 2000.
20. Analytical Methods Committee. Analyst 120 (1995) 2303-2308
21. Hund E., Massart D.L., and Smeyers-Verbeke J. Anal. Chim. Acta 480 (2003) 39-52
22. Feinberg M., Boulanger B., Dewé W., and Hubert Ph. Anal. Bioanal. Chem. 380 (2004) 502-514
23. Marini R.D., Boulanger B., Vander Heyden Y., Chiap P., Crommen J., and Hubert Ph. Anal. Chim. Acta 531 (2005) 131-140
24. ISO/IEC Standards 5725-2, Accuracy (trueness and precision) of measurement methods and results, 1994.
25. Servais A.-C., Fillet M., Chiap P., Dewé W., Hubert Ph., and Crommen J. Electrophoresis 25 (2004) 2701-2710
26. The European Pharmacopoeia, fifth ed., Council of Europe, Strasbourg, France, 2005.
27. Plackett R.L., and Burman J.P. Biometrika 33 (1946) 305-325
28. Wätzig H., and Dette C. J. Chromatogr. 636 (1993) 31-38
29. Marini R.D., Chiap P., Boulanger B., Dewé W., Hubert Ph., and Crommen J. J. Sep. Sci. 26 (2003) 809-817
30. H. Fabre, K.D. Altria, LC GC Europe, CE Currents May 2001, p. 1, www.lcgceurope.com.
31. Vander Heyden Y., Luypaert K., Hartman C., Massart D.L., Hoogmartens J., and de Beer J. Anal. Chim. Acta 312 (1995) 245-262
32. Perrin C., Fabre H., Massart D.L., and Vander Heyden Y. Electrophoresis 24 (2003) 2469-2480
33. Vander Heyden Y., Saevels J., Roets E., Hoogmartens J., Decolin D., Quaglia M.G., Van den Bossche W., Leemans R., Smeets O., Van de Vaart F., Mason B., Taylor G.C., Underberg W., Bult A., Chiap P., Crommen J., De Beer J., Hansen S.H., and Massart D.L. J. Chromatogr. A 830 (1999) 3-28
34. Dehouck P., Vander Heyden Y., Smeyers-Verbecke J., Massart D.L., Marini R.D., Chiap P., Hubert Ph., Crommen J., Van de Wauw W., De Beer J., Cox R., Mathieu G., Reepmeyer J.C., Voigt B., Estevenon O., Nicolas A., Van Schepdael A., Adams A., and Hoogmartens J. J. Chromatogr. A 1010 (2003) 63-74
35. Kelly P.C. J. Assoc. Off. Anal. Chem. 73 (1990) 58-64
36. Marini R.D., Matthijs N., Vander Heyden Y., Smeyers-Verbeke J., Dehouck P., Hoogmartens J., Silvestre P., Ceccato A., Goedert Ph., Saevels J., Herbots C., Caliaro G., Herráez-Hernández R., Verdú-Andrès J., Campíns-falcó P., Van de Wauw W., De Beer J., Boulanger B., Chiap P., Crommen J., and Hubert Ph. Anal. Chim. Acta 546 (2005) 182-192
37. Horwitz W., Kamps L.R., and Boyer K.W. J. Assoc. Off. Anal. Chem. 63 (1980) 1344-1354