Reliability of simulated robustness testing in fast liquid chromatography, using state-of-the-art column technology, instrumentation and modelling software

Journal of Pharmaceutical and Biomedical Analysis

Volumn 89, Issue , 2014, Pages 67-75

  Kormány, Róbert ^a   Fekete, Jeno ^b   Guillarme, Davy ^c   Fekete, Szabolcs ^c  

^a EGIS PHARMACEUTICALS LTD   (Hungary)

^b BUDAPEST UNIVERSITY OF TECHNOLOGY AND ECONOMICS   (Hungary)

^c UNIVERSITY OF GENEVA   (Switzerland)

Author keywords

Column interchangeability; DryLab; Method development; Modelling software; Robustness; UHPLC

Indexed keywords

AMLODIPINE;

ARTICLE; COMPUTER PROGRAM; ENTHALPY; HYDROGEN BOND; HYDROPHOBICITY; PH; PRIORITY JOURNAL; RELIABILITY; TEMPERATURE; TIME; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY;

COLUMN INTERCHANGEABILITY; DRYLAB; METHOD DEVELOPMENT; MODELLING SOFTWARE; ROBUSTNESS; UHPLC;

AMLODIPINE; CHROMATOGRAPHY, LIQUID; MODELS, CHEMICAL; REPRODUCIBILITY OF RESULTS; SOFTWARE;

EID: 84887802305     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2013.10.029     Document Type: Article

References (35)

1. Monks K., Molnár I., Rieger H.J., Bogáti B., Szabó E. Quality by Design: Multidimensional exploration of the design space in high performance liquid chromatography method development for better robustness before validation. J. Chromatogr. A 2012, 1232:218-230.
2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R1), Current Step 4 version, Parent Guideline dated 27 October 1994 (Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf.
3. Bliesner D.M. Validating Chromatographic Methods 2006, Wiley-Interscience, New Jersey.
4. Dejaegher B., Vander Heyden Y. Ruggedness and robustness testing. J. Chromatogr. A 2007, 1158:138-157.
5. Vander Heyden Y., Nijhuis A., Smeyers-Verbeke J., Vandeginste B.G.M., Massart D.L. Guidance for robustness/ruggedness tests in method validation. J. Pharm. Biomed. Anal. 2001, 24:723-753.
6. Dong M.W. Modern HPLC for Practicing Scientists 2006, Wiley-Interscience, New Jersey.
7. Hou J.J., Wu W.Y., Da J., Yao S., Long H.L., Yang Z., Cai L.Y., Yang X., Liu B.H.J., Guo D.A. Ruggedness and robustness of conversion factors in method of simultaneous determination of multi-components with single reference standard. J. Chromatogr. A 2011, 1218:5618-5627.
8. Novokmet M., Pučić M., Redžić I., Mužinić A., Gornik O. Robustness testing of the high throughput HPLC-based analysis of plasma N-glycans. Biochim. Biophys. Acta 2012, 1820:1399-1404.
9. Ragonese R., Mulholland M., Kalman J. Full and fractionated experimental designs for robustness testing in the high-performance liquid chromatographic analysis of codeine phosphate, pseudoephedrine hydrochloride and chlorpheniramine maleate in a pharmaceutical preparation. J. Chromatogr. A 2000, 870:45-51.
10. Hund E., Vander Heyden Y., Haustein M., Massart D.L., Smeyers-Verbeke J. Robustness testing of a reversed-phase high-performance liquid chromatographic assay: comparison of fractional and asymmetrical factorial designs. J. Chromatogr. A 2000, 874:167-185.
11. Debrus B., Guillarme D., Rudaz S. Improved quality-by-design compliant methodology for method development in reversed-phase liquid chromatography. J. Pharm. Biomed. Anal. 2013, 84:215-223.
12. Guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Pharmaceutical Development, Q8(R2) Step 4, 2009, pp. 1-24.
13. Debrus B., Lebrun P., Ceccato A., Caliaro G., Rozet E., Nistor I., Oprean R., Rupérez F.J., Barbas C., Boulanger B., Hubert P. Application of new methodologies based on design of experiments, independent component analysis and design space for robust optimization in liquid chromatography. Anal. Chim. Acta 2011, 691:33-42.
14. Debrus B., Lebrun P., Kindenge J.M., Lecomte F., Ceccato A., Caliaro G., Mavar Tayey Mbay J., Boulanger B., Marini R.D., Rozet E., Hubert P.H. Innovative highperformance liquid chromatography method development for the screening of 19 antimalarial drugs based on a generic approach, using design of experiments, independent component analysis and design space. J. Chromatogr. A 2011, 1218:5205-5215.
15. Fekete S., Fekete J., Molnár I., Ganzler K. Rapid high performance liquid chromatography method development with high prediction accuracy, using 5cm long narrow bore columns packed with sub-2(m particles and Design Space computer modelling. J. Chromatogr. A 2009, 1216:7816-7823.
16. Fekete S., Rudaz S., Fekete J., Guillarme D. Analysis of recombinant monoclonal antibodies by RPLC: Toward a generic method development approach. J. Pharm. Biomed. Anal. 2012, 70:158-168.
17. Schmidt A.H., Molnár I. Using an innovative Quality-by-Design approach for development of a stability indicating UHPLC method for ebastine in the API and pharmaceutical formulations. J. Pharm. Biomed. Anal. 2013, 78-79(78):65-70.
18. Kormány R., Rieger H.J., Molnár I. Application of quality by design principles to a pharmaceutical sample using UHPLC method development with modeling technologies. LC-GC 2013, 31:20-27.
19. Krisko R.M., McLaughlin K., Koenigbauer M.J., Lunte C.E. Application of a column selection system and DryLab software for high-performance liquid chromatography method development. J. Chromatogr. A 2006, 1122:186-193.
20. Kimata K., Iwaguchi K., Onishi S., Jinno K., Eksteen R., Hosoya K., Araki M., Tanaka N. Chromatographic Characterization of Silica C18 Packing Materials. Correlation between a preparation method and retention behavior of stationary phase. J. Chromatogr. Sci. 1989, 27:721-728.
21. Wilson N.S., Nelson M.D., Dolan J.W., Snyder L.R., Wolcott R.G., Carr P.W. Column selectivity in reversed-phase liquid chromatography I. A general quantitative relationship. J. Chromatogr. A 2002, 961:171-193.
22. Lewis J.A., Snyder L.R., Dolan J.W. Initial experiments in high-performance liquid chromatographic method development II. Recommended approach and conditions for isocratic separation. J. Chromatogr. A 1996, 721:15-29.
23. Dolan J.W., Snyder L.R., Djordjevic N.M., Hill D.W., Saunders D.L., Van Heukelem L., Waeghe T.J. Simultaneous variation of temperature and gradient steepness for reversed-phase high-performance liquid chromatography method development: I. Application to 14 different samples using computer simulation. J. Chromatogr. A 1998, 803:1-31.
24. Snyder L.R., Kirkland J.J., Glajch J.L. Practical HPLC Method Development 1997, John Wiley & Sons Inc. second ed.
25. Kormány R., Molnár I., Rieger H.J. Exploring better column selectivity choices in ultra-high performance liquid chromatography using Quality by Design principles. J. Pharm. Biomed. Anal. 2013, 80:79-88.
26. Heinisch S., Rocca J.-L. Sense and non-sense of high-temperature liquid chromatography. J. Chromatogr. A 2009, 1216:642-658.
27. Melander W.R., Stoveken J., Horváth Cs. Mobile phase effects in reversed-phase chromatography: II. Acidic amine phosphate buffers as eluents. J. Chromatogr. 1979, 185:111-127.
28. Castells C.B., Rafols C., Roses M., Bosch E. Effect of temperature on the chromatographic retention of ionizable compounds: I. Methanol-water mobile phases. J. Chromatogr. A 2004, 1042:23-35.
29. Dolan J.W., Snyder L.R. Developing a Gradient Elution Method for Reversed-Phase HPLC. LC-GC 1988, 5:970-978.
30. Snyder L.R. Gradient elution. HPLC: Advances and Perspectives, Vol. 1 1980, 208-316. Academic Press, New York. C. Horvath (Ed.).
31. Euerby M.R., Jamesa M., Petersson P. Practical implications of the Tanaka stationary phase characterization methodology using ultra high performance liquid chromatographic conditions. J. Chromatogr. A 2012, 1228:165-174.
32. Euerby M.R., James M., Axelsson B.O., Rosén O., Petersson P. Validation of the extended Tanaka column characterization protocol by multivariate analysis of chromatographic retention of low-molecular-weight analytes on reversed phase columns using methanol and acetonitrile as organic modifiers. J. Sep. Sci. 2012, 35:2592-2598.
33. Dolan J.W., Snyder L.R., Blanc T., Van Heukelem L. Selectivity differences for C18 reversed-phase columns as a function of temperature and gradient steepness. I. Optimizing selectivity and resolution. J. Chromatogr. A 2000, 897:37-50.
34. Molnár I., Rieger H.-J., Monks K.E. Aspects of the design space in high pressure liquid chromatography method development. J. Chromatogr. A 2010, 1217:3193-3200.
35. Molnár I., Rieger H.J., Kormány R. Chromatography modelling in high performance liquid chromatography method development. Chrom. Today 2013, 3-8.