Role of organic modifier and gradient shape in RP-HPLC separation: Analysis of GCSF variants

Journal of Chromatographic Science

Volumn 53, Issue 3, 2015, Pages 417-423

  Joshi, Varsha S ^a   Kumar, Vijesh ^a   Rathore, Anurag S ^a  

^a INDIAN INSTITUTE OF TECHNOLOGY DELHI   (India)

Author keywords

[No Author keywords available]

Indexed keywords

GRANULOCYTE COLONY STIMULATING FACTOR;

CHEMISTRY; DEVICES; EVALUATION STUDY; GENETICS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; ISOLATION AND PURIFICATION; OXIDATION REDUCTION REACTION; PROCEDURES; REVERSED PHASE LIQUID CHROMATOGRAPHY;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CHROMATOGRAPHY, REVERSE-PHASE; GRANULOCYTE COLONY-STIMULATING FACTOR; HUMANS; OXIDATION-REDUCTION;

EID: 84937632900     PISSN: 00219665     EISSN: None     Source Type: Journal    
DOI: 10.1093/chromsci/bmu222     Document Type: Article

References (49)

1. Rathore, A. S.; Follow-on protein products: scientific issues, developments and challenges; Trends in Biotechnology, (2009); 27:698-705.
2. Krull, I. S., Rathore, A. S.; Analytical tools for characterization of biotechnology products and processes; LCGC North America, (2010); 29:454.
3. Mendhe, R., Krull, I. S., Rathore, A. S.; Analytical tools for enabling process analytical technology applications in biotechnology; LC GC North America, (2012);
4. Pharm. Tech., 2012;30(1):52-62.
5. Rathore, A. S., Bhambure, R.; Establishing analytical comparability for "Biosimilars": filgrastim as a case study; Analytical and Bioanalytical Chemistry, (2014); 406:6569-6576.
6. Horvath, C., Melander, W.; Liquid chromatography with hydrocarbonaceous bonded phases; theory and practice of reversed phase chromatography; Journal of Chromatographic Science, (1977); 15(9):393-404.
7. Colin, H., Guiochon, G.; Introduction to reversed-phase highperformance liquid chromatography; Journal of Chromatography A, (1977); 141(3):289-312.
8. Karger, B. L., Giese, R. W.; Reversed phase liquid chromatography and its application to biochemistry; Analytical Chemistry, (1978); 50(12):1048A-1073A.
9. Karch, K., Sebestian, I., Halasz, I.; Preparation and properties of reversed phases; Journal of Chromatography A, (1976); 122:3-16.
10. Martire, D. E., Boehm, R. E.; Unified theory of retention and selectivity in liquid chromatography. 2. Reversed-phase liquid chromatography with chemically bonded phases; The Journal of Physical Chemistry, (1983); 87(6):1045-1062.
11. Gazdag, M., Szepesi, G., Szeleczki, E.; Selection of high-performance liquid chromatographic methods in pharmaceutical analysis: I. Optimization for selectivity in reversed-phase chromatography; Journal of Chromatography A, (1988); 454:83-94.
12. Locke, D. C.; Selectivity in reversed-phase liquid chromatography using chemically bonded stationary phases; Journal of Chromatographic Science, (1974); 12(8):433-437.
13. Melander, W. R., Chen, B. K., Horvàth, C.; Mobile phase effects in reversed-phase chromatography: I. Concomitant dependence of retention on column temperature eluent composition; Journal of Chromatography A, (1979); 185:99-109.
14. Valko, K., Snyder, L. R., Glajch, J. L.; Retention in reversed-phase liquid chromatography as a function of mobile-phase composition; Journal of Chromatography A, (1993); 656(1):501-520.
15. Glajch, J. L., Kirkland, J. J., Squire, K. M., Minor, J. M.; Optimization of solvent strength and selectivity for reversed-phase liquid chromatography using an interactive mixture-design statistical technique; Journal of Chromatography A, (1980); 199:57-79.
16. Cohen, K. A., Schellenberg, K., Benedek, K., Karger, B. L., Grego, B., Hearn, M. T. W.; Mobile-phase and temperature effects in the reversed phase chromatographic separation of proteins; Analytical Biochemistry, (1984); 140(1):223-235.
17. Berendsen, G. E., De Galan, L.; Role of the chain length of chemically bonded phases and the retention mechanism in reversed-phase liquid chromatography; Journal of Chromatography A, (1980); 196(1):21-37.
18. Horvath, C., Melander, W., Molnar, I., Molnar, P.; Enhancement of retention by ion-pair formation in liquid chromatography with nonpolar stationary phases; Analytical Chemistry, (1977); 49(14):2295-2305.
19. Coenegracht, P. M. J., Metting, H. J., Smilde, A. K., Coenegracht-Lamers, P. J. M.; A chemometric investigation of the selectivity of multisolvent mobile phase systems in RP-HPLC; Chromatographia, (1989); 27(3-4):135-141.
20. Coenegracht, P. M. J., Smilde, A. K., Knevelman, A.; Performance characterization of multi-solvent mobile phase systems in RP-HPLC by multi-criteria decision making illustrated by the comparison of ternary and quaternary solvent systems; Journal of Liquid Chromatography, (1989); 12(1-2):77-94.
21. Coenegracht, P. M. J., Smilde, A. K., Metting, H. J., Doornbos, D. A.; Comparison of optimization methods in reversed-phase highperformance liquid chromatography using mixture designs and multi-criteria decision making; Journal of Chromatography A, (1989); 485:195-217.
22. Coenegracht, P. M. J., Van Tuyen, N., Metting, H. J., Coenegracht-Lamers, P. J. M.; Application of a mixture design technique to the simultaneous optimization of analysis time and resolution in reversed-phase ion-pair liquid chromatography using a minimal resolution plot; Journal of Chromatography A, (1987); 389:351-367.
23. ® computer simulation for high-performance liquid chromatographic method development: II. Gradient elution; Journal of Chromatography A, (1989); 485:91-112.
24. Fitzpatrick, F., Edam, R., Schoenmakers, P.; Application of the reversed-phase liquid chromatographic model to describe the retention behaviour of polydisperse macromolecules in gradient and isocratic liquid chromatography; Journal of Chromatography A, (2003); 988(1):53-67.
25. Vivó-Truyols, G., Torres-Lapasió, J. R., Garcia-Alvarez-Coque, M. C.; Enhanced calculation of optimal gradient programs in reversedphase liquid chromatography; Journal of Chromatography A, (2003); 1018(2):183-196.
26. ® computer simulation for high-performance liquid chromatographic method development: I. Isocratic elution; Journal of Chromatography A, (1989); 485:65-89.
27. Snyder, L. R., Dolan, J. W., Quarry, M. A.; High-performance liquid chromatographic method-development using computer simulation; TrAC Trends in Analytical Chemistry, (1987); 6(5):106-111.
28. Jandera, P., Churacek, J.; Liquid chromatography with programmed composition of the mobile phase; Advances in Chromatography, (1981); 19:125.
29. Jandera, P., Churácek, J.; Gradient elution in column liquid chromatography: theory and practice. Elsevier (1985). Amsterdam, Netherlands.
30. Glajch, J. L., Quarry, M. A., Vasta, J. F., Snyder, L. R.; Separation of peptide mixtures by reversed-phase gradient elution. Use of flow rate changes for controlling band spacing and improving resolution; Analytical Chemistry, (1986); 58(2):280-285.
31. Snyder, L. R., Stadalius, M. A., Quarry, M. A.; Gradient elution in reversed-phase HPLC-separation of macromolecules; Analytical Chemistry, (1983); 55(14):1412A-1430A.
32. Banes, A. J., Link, G. W., Snyder, L. R.; Comparison of reversed-phase columns for the separation of tryptic peptides by gradient elution: correlation of experimental results and model prediction; Journal of Chromatography A, (1985); 326:419-431.
33. Stadalius, M. A., Gold, H. S., Snyder, L. R.; Optimization model for the gradient elution separation of peptide mixtures by reversed-phase high-performance liquid chromatography: verification of retention relationships; Journal of Chromatography A, (1984); 296:31-59.
34. Stadalius, M. A., Gold, H. S., Snyder, L. R.; Optimization model for the gradient elution separation of peptide mixtures by reversed-phase high-performance liquid chromatography: verification of band width relationships for acetonitrile-water mobile phases; Journal of Chromatography A, (1985); 327:27-45.
35. Hearn, M. T., Grego, B.; High-performance liquid chromatography of amino acids, peptides and proteins: XL. Further studies on the role of the organic modifier in the reversed-phase high-performance liquid chromatography of polypeptides. Implications for gradient optimisation; Journal of Chromatography A, (1983); 255:125-136.
36. Zhu, P. L., Snyder, L. R., Dolan, J. W., Djordjevic, N. M., Hill, D. W., Sander, L. C., et al. Combined use of temperature and solvent strength in reversed-phase gradient elution I. Predicting separation as a function of temperature and gradient conditions; Journal of Chromatography A, (1996); 756(1):21-39.
37. Shan, Y., Seidel-Morgenstern, A.; Optimization of gradient elution conditions in multicomponent preparative liquid chromatography; Journal of Chromatography A, (2005); 1093(1):47-58.
38. Jandera, P., Kucerova, Z., Urban, J.; Retention times and bandwidths in reversed-phase gradient liquid chromatography of peptides and proteins; Journal of Chromatography A, (2011); 1218(49):8874-8889.
39. Tarafder, A., Aumann, L., Muller-Spath, T., Morbidelli, M.; Improvement of an overloaded, multi-component, solvent gradient bioseparation through multiobjective optimization; Journal of Chromatography A, (2007); 1167(1):42-53.
40. Jandera, P.; Simultaneous optimisation of gradient time, gradient shape and initial composition of the mobile phase in the highperformance liquid chromatography of homologous and oligomeric series; Journal of Chromatography A, (1999); 845(1):133-144.
41. Jandera, P.; Gradient elution in liquid column chromatography-prediction of retention and optimization of separation; Advances in Chromatography, (2005); 43: I.
42. Damtew, A., Sreedhar, B., Seidel-Morgenstern, A.; Evaluation of the potential of nonlinear gradients for separating a ternary mixture; Journal of Chromatography A, (2009); 1216(28):5355-5364.
43. Schoenmakers, P. J., Blaffert, T.; Effect of model inaccuracy on selectivity optimization procedures in reversed-phase liquid chromatography; Journal of Chromatography A, (1987); 384:117-133.
44. Ghrist, B. F. D., Cooperman, B. S., Snyder, L. R.; Design of optimized highperformance liquid chromatographic gradients for the separation of either small or large molecules: I. Minimizing errors in computer simulations; Journal of Chromatography A, (1988); 459:1-23.
45. Aritomi, M., Kunishima, N., Okamoto, T., Kuroki, R., Ota, Y., Morikawa, K.; Atomic structure of the GCSF-receptor complex showing a new cytokine-receptor recognition scheme; Nature, (1999); 401:713-717.
46. Petit, I., Szyper-Karavitz, M., Nagler, A., Lahav, M., Peled, A., Habler, L., et al.; G-CSF induces stem cell mobilization by decreasing bone marrow SDF-1 and up-regulating CXCR4; Nature Immunology, (2002); 3:687-694.
47. Lu, H. S., Clogston, C. L., Narhi, L. O., Merewether, L. A., Pearl, W. R., Boone, T. C.; Folding and oxidation of recombinant human granulocyte colony stimulating factor produced in Escherichia coli. Characterization of the disulfide-reduced intermediates and cysteine-serine analogs; Journal of Biological Chemistry, (1992); 267(13):8770-8777.
48. European Directorate for the Quality of Medicines; Filgrastim concentrated solution: European Pharmacopoeia Monograph 7:2015-2018.
49. Dolan, J. W., Snyder, L. R. "Gradient Elution Chromatography" Encyclopedia of Analytical Chemistry. John Wiley & Sons, Ltd. (2012), pp. 1-19. doi:10.1002/9780470027318.a5907.pub2.