Enhancing productivity in the analytical laboratory through the use of ultra fast-HPLC in preformulation/formulation development

Journal of Liquid Chromatography and Related Technologies

Volumn 31, Issue 15, 2008, Pages 2253-2285

  LoBrutto, Rosario ^a   Makarov, Alexey ^a   Jerkovich, Anton ^a   McGill, Raymond ^a   Kazakevich, Yuri ^b   Vivilecchia, Richard ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

^b SETON HALL UNIVERSITY   (United States)

Author keywords

Basic compounds; Formulation development; Liophilic; PKa; Preformulation developments; UHPLC; UPLC

Indexed keywords

ARSENIC COMPOUNDS; CHEMICAL LABORATORIES; CHEMOTHERAPY; CHLORINE COMPOUNDS; DECISION MAKING; DOPING (ADDITIVES); DRUG DELIVERY; DRUG DOSAGE; DRUG PRODUCTS; DRUG PRODUCTS PLANTS; LABORATORIES; PHASE SEPARATION; PROBLEM SOLVING; SEPARATION; SPEED; TECHNOLOGY; WASTE DISPOSAL;

ANALYTE; ANALYTICAL TECHNOLOGIES; BASIC COMPOUNDS; CHROMATOGRAPHIC METHODS; DRUG DISCOVERIES; EFFECTIVE TOOL; FORMULATION DEVELOPMENT; HIGH PRESSURES; HIGH SPEEDS; LIOPHILIC; METHOD DEVELOPMENT; MOBILE PHASE ADDITIVES; MULTIPLY CHARGED; OPERATING PRESSURES; PEAK SYMMETRY; PHARMACEUTICAL COMPANIES; PHARMACEUTICAL INDUSTRIES; PKA; PREFORMULATION DEVELOPMENTS; SEPARATION SELECTIVITY; SYSTEMATIC METHODS; UHPLC; ULTRA-FAST; UPLC;

HIGH PRESSURE LIQUID CHROMATOGRAPHY;

SOLVENT;

ARTICLE; AUTOMATION; DECISION MAKING; DRUG INDUSTRY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PREFORMULATION; PRESSURE; TECHNOLOGY; WASTE DISPOSAL;

EID: 49449100511     PISSN: 10826076     EISSN: 1520572X     Source Type: Journal    
DOI: 10.1080/10826070802279467     Document Type: Article

References (42)

1. Cain, M.; Kirsch, S. The future of pharmaceuticals. health care horizons. Institute for the Future 2001, SR-756.
2. An industrial revolution in R&D by PricewaterhouseCoopers, Pharma 2005.
3. Zhang, Y.; Wu, D.R.; Wang-Iverson, D.B.; Tymiak, A.A. Enantioselective chromatography in drug discovery. Drug Discovery Today 2005, 10, 571-577.
4. Workman, P. How much gets there and what does it do?: The need for better pharmacokinetic and pharmacodynamic endpoints in contemporary drug discovery and development. Curr. Pharm. Des. 2003, 9, 891-902.
5. Swartz, M.E. UHPLC™: An Introduction and review. J. Liq. Chromatogr. Relat. Technologies 2005, 28(7), 1253-1263.
6. de Villiers, A.; Lestremau, F.; Szucs, R.; Gelebart, S.; David, F.; Sandra, P. Evaluation of ultra performance liquid chromatography. Part I. Possibilities and limitations. J. Chrom. A 2006, 1127, 60-69.
7. Mazzeo, J.R.; Neue, U.D.; Kele, M.; Plumb, R.S. Advancing LC performance with smaller particles and higher pressures. Anal. Chem. 2005, 77, 460A-467A.
8. Wu, N.; Clausens, A. Fundamental and practical aspects of ultrahigh pressure liquid chromatography for fast separations. J. Sep. Sci. 2007, 30, 1167-1182.
9. Thompson, J.W.; Mellors, J.S.; Eschelbach, J.W.; Jorgenson, J.W. Recent advances in ultrahigh-pressure liquid chromatography. LC-GC North America 2006, 16, 18-20.
10. McCalley, D.V. Comparison of conventional microparticulate and a monolithic reversed-phase column for high-efficiency fast liquid chromatography of basic compounds. J. Chromatography A 2002, 965, 51-64.
11. Kele, M.; Guichon, G. Repeatability and reproducibility of retention data and band profiles on reversed-phase liquid chromatography columns I. Experimental protocol. J. Chromatography A 2002, 960, 19-49.
12. Tanaka, N.; Kobayasahi, H.; Ishiuka, N.; Minakuchi, J.H.; Nakanishi, K.; Hosoya, K.; Ikegami, T. Monolithic silica columns for high-efficiency chromatographic separations. J. Chromatogr. A 2002, 965, 35.
13. Wang, X.; Barber, W.E.; Carr, P.W. A practical approach to maximizing peak capacity by using long columns packed with pellicular stationary phases for proteomic research. J. Chromatogr. A 2006, 1107, 139-151.
14. Vanhoenacker, G.; Sandra, P. Elevated temperature and temperature programming in conventional liquid chromatography - fundamentals and applications. J. Sep. Sci. 2006, 29, 1822-1835.
15. Lestremau, F.; Cooper, A.; Szucs, R.; David, F.; Sandra, P. High-efficiency liquid chromatography on conventional columns and instrumentation by using temperature as a variable I. Experiments with 25 cm x 4.6 mm I.D., 5μm ODS columns. J. Chromatogr. A 2006, 1109, 191.
16. MacNair, J.E.; Lewis, K.C.; Jorgenson, J.W. Ultrahigh-pressure reversed-phase liquid chromatography in packed capillary columns. Anal. Chem. 1997, 69, 983-989.
17. MacNair, J.E.; Patel, K.D.; Jorgenson, J.W. Ultrahigh-pressure reversed-phase capillary liquid chromatography: isocratic and gradient elution using columns packed with 1.0-μm particles. Anal. Chem. 1999, 71, 700-708.
18. Jerkovich, A.D.; Vivilecchia, R.V. Chapter 17: Development of Fast HPLC Methods, HPLC for Pharmaceutical Scientists, ed. Y. Kazakevich and R. LoBrutto, John Wiley & Sons, 2007, pp. 765-807.
19. Johnson, K.A.; Plumb, R. Investigating the human metabolism of acetaminophen using UHPLC and exact mass oa-TOF MS. J. Pharm. Biomed. Anal. 2005, 39, 805-810.
20. Beattie, I.; Joncour, K.; Lawson, K. Ultra performance liquid chromatography coupled to orthogonal quadrupole TOF-MS(MS) for metabolite identification. Separation Science Redefined. Supplement to LCGC, May 2005, 22-30.
21. Shen, J.X.; Wang, H.; Tadros, S.; Hayes, R.N. Orthogonal extraction/chromatography and UHPLC, two powerful new techniques for bioanalytical quantitation of desloratadine and 3-hydroxydesloratadine at 25pg/mL. J. Pharm. Biomed. Anal. 2006, 40(3), 689-706.
22. Jerkovich, A.D.; LoBrutto, R.; Vivilecchia, R.V. The Use of ACQUITY UHPLC in Pharmaceutical Development. Separation Science Redefined. Supplement to LC-GC, May 2005, 15-21.
23. Sun, X.; Wrisley, L. A systematic approach to convert ultra-fast HPLC conditions to conventional HPLC conditions. American Drug Discovery June/July 2007, 2(4), 22-30.
24. Yang, Y.; Hodges, C.C. The use of ACQUITY UPLC in pharmaceutical development. LC-GC Europe 2005, 28-32.
25. Wren, S.A.C.; Tchelitcheff, P. Use of ultra-performance liquid chromatography in pharmaceutical development. J. Chromatogr. A 2006, 1119, 140-146.
26. Scheidegger, A.E. The Physics of Flow through Porous Media. University of Toronto Press, 1960.
27. Stone, M.A. Mathematics of optimization and scaling for the practicing chromatographer. J. Liq. Chromatography and Related Technologies 2007, 5-7, 605-647.
28. Neue, U.D. HPLC Columns. Wiley VCH, New York, 1997, p. 90.
29. Nikitas, P.; Pappa-Louisi, A. New equations describing the combined effect of pH and organic modifier concentration on the retention in reversed-phase liquid chromatography. J. Chromatogr. A 2001, 971, 47-60.
30. Kaliszan, R.; Wiczling, P.; Markuszewski, M.J. pH gradient high-performance liquid chromatography: theory and applications. J. Chromatogr. A 2004, 1060, 165-175.
31. Heinisch, S.; Rocca, J.L. Effect of mobile phase composition, pH and buffer type on the retention of ionizable compounds in reversed-phase liquid chromatography: application to method development. J. Chromatogr. A 2004, 1048, 183-193.
32. Horvath, Cs.; Melander, W.; Molnar, I. Liquid chromatography of ionogenic substances with nonpolar stationary phases. Anal. Chem. 1977, 49, 142-154.
33. LoBrutto, R.; Jones, A.; Kazakevich, Y. Effect of counteranion concentration on hplc retention of protonated basic analytes. J. Chromatogr. A 2001, 913, 189-196.
34. Pilorz, K.; Choma, I. Isocratic reversed-phase high-performance liquid chromatographic separation of tetracyclines and flumequine controlled by a chaotropic effect. J. Chromatogr. A 2004, 1031, 303-311.
35. Flieger, J. The effect of chaotropic mobile phase additives on the separation of selected alkaloids in reversed phase high performance liquid chromatography. J. Chromatogr. A 2006, 1113, 37-44.
36. Jones, A.; LoBrutto, R.; Kazakevich, Y.V. Effect of the counter-anion type and concentration on the liquid chromatography retention of β-blockers. J. Chromatogr. A 2002, 964, 179-187.
37. Hashem, H.; Jira, T. Effect of chaotropic mobile phase additives on retention behaviour of beta-blockers on various reversed-phase high-performance liquid chromatography columns. Journal of Chromatography A 2006, 1133 (1-2), 69-75.
38. Flieger, J. Effect of mobile phase composition on the retention of selected alkaloids in reversed-phase liquid chromatography with chaotropic salts. Journal of Chromatography A. 2007, 1175, 207-216.
39. Pan, L.; LoBrutto, R.; Kazakevich, Y.V.; Thompson R. Influence of inorganic mobile phase additives on the retention, efficiency and peak symmetry of protonated basic compounds in reversed-phase liquid chromatography. Journal of Chromatography A 2004, 1049, 63-73.
40. Makarov, A.; LoBrutto, R.; Jerkovich, A.; Cristodoulatos, C. The Use of Sub-2-micron Particles Columns and Chaotropic Mobile Phase Additives in Liquid Chromatography for the Analysis of Small Molecules and Proteins/Peptides, Eastern Analytical Symposium, November 2007, Somerset, NJ.
41. Advanced Chemistry Development, version 8, Toronto, Canada.
42. Kazakevich, Y.V.; LoBrutto, R. HPLC for Pharmaceutical Scientists; Yuri K., Rosario L., Eds.; Chapter 4, Jan 2007, pp. 139-228.