Expanding the term "Design Space" in high performance liquid chromatography (I)

Journal of Pharmaceutical and Biomedical Analysis

Volumn 56, Issue 5, 2011, Pages 874-879

  Monks, K E ^a   Rieger, H J ^a   Molnar I ^a  

^a Molnár Institute for Applied Chromatography   (Germany)

Author keywords

3 D computer modeling software; Design Space; HPLC method development; Quality by Design; Snyder Dolan hydrophobic subtraction model of RPLC phase selectivity

Indexed keywords

ARTICLE; COLUMN DESIGN SPACE; COMPUTER MODEL; COMPUTER PROGRAM; ELUENT DESIGN SPACE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PH; PRIORITY JOURNAL; TEMPERATURE;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HYDROGEN-ION CONCENTRATION; MODELS, THEORETICAL;

EID: 80052801345     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2011.04.015     Document Type: Article

References (23)

1. L.R. Snyder, J.L. Glajch, Computer-assisted Method Development for High-performance Liquid Chromatography, Elsevier, Amsterdam, 1990 (also J. Chromatogr. 485 (1989)).
2. ICH Q8 - Guidance for Industry, Pharmaceutical Development, 2006.
3. ICH Q9 - Quality Risk Management, 2006.
4. ICH Q10 - Pharmaceutical Quality System, 2009.
5. M. Nasr, CDER, FDA, Lecture on " Quality by Design (QbD): Analytical Aspects" at HPLC 2009, Dresden, Germany, September 2009.
6. R. Luigetti, EMEA, Lecture on " QbD: A Global Implementation Perspective The EU Perspective" at the Siena Conference on Product and Process Optimization, October 2008.
7. Erni F. Presentation at the Scientific Workshop Computerized Design of Robust Separations in HPLC and CE 2008.
8. 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.
9. McBrien M. Practical Implications of quality by Design to chromatographic method development. Chromatogr. Today 2010, 3:30-34.
10. Li Y., Terfloth G.J., Kord A.S. A systematic approach to RP-HPLC method development in a pharmaceutical QbD environment. Am. Pharm. Rev. 2009.
11. Schweitzer M., et al. Implications and opportunities of applying the principles of quality by design to analytical measurements. Pharm. Technol. 2010, 34.
12. Ermer J., Miller J.H.McB. Method Validation in Pharmaceutical Analysis 2005, Wiley-VCH, Weinheim, p. 131.
13. Euerby M.R., Schad G., Rieger H.-J., Molnár I. 3-Dimensional retention modelling of gradient time, ternary solvent-strength and temperature of the reversed-phase gradient liquid chromatography of a complex mixture of 22 basic and neutral analytes using DryLab® 2010. Chromatogr. Today 2010, 3:13-20.
14. ICH Q8 (R2) - Guidance for Industry, Pharmaceutical Development, 2009.
15. Horváth Cs., Melander W., Molnár I., Molnár P. Enhancement of retention by ion-pair formation in liquid chromatography with nonpolar stationary phases (Solvophobic theory of reversed phase chromatography, Part III). Anal. Chem. 1977, 49:2295-2305.
16. Snyder L.R., Dolan J.W., Carr P.W. The " hydrophobic-subtraction" model of reversed-phase column selectivity. J. Chromatogr. A 2004, 1060:77-116.
17. Snyder L.R., Dolan J.W., Car P.W. A new look at the selectivity of reversed-phase HPLC columns. Anal. Chem. 2007, 79:3255-3261.
18. Snyder L.R., Maule A., Heebsch A., Cuellar R., Paulson S., Carrano J., Wrisley L., Chan C.C., Pearson N., Dolan J.W., Gilroy J. A fast, convenient and rugged procedure for characterizing the selectivity of alkyl-silica columns. J. Chromatogr. A 2004, 1057:49-57.
19. Dolan J.W., Maule A., Wrisley L., Chan C.C., Angod M., Lunte C., Krisko R., Winston J., Homeierand B., McCalley D.M., Snyder L.R. Choosing an equivalent replacement column for a reversed-phase liquid chromatographic assay procedure. J. Chromatogr. A 2004, 1057:59-74.
20. Molnár I. Computerized design of separation strategies in reversed-phase liquid chromatography: development of DryLab software. J. Chromatogr. A 2002, 965:175-194.
21. Snyder L.R., Kirkland J.J., Glajch J.L. Practical HPLC Method Development 1997, Wiley-Interscience, NY, p. 888. 2nd ed.
22. Makarov A., Chen Z., Chan F., Bhashyam R., LoBrutto R., Vegesna R. A Strategy for Improving HPLC - Retention Time Prediction Accuracy Using Chromatography Simulation Software October 2010, American Laboratory.
23. L. Wrisley, Pfizer, Lecture on " Column Selectivity Database Application to HPLC Method Development: A QbD Perspective" at Pittsburgh Conference, Orlando, USA, March 2010.