167
Views
1
CrossRef citations to date
0
Altmetric
Articles

Continuous screening of analytical parameters facilitates efficient development of HPLC methods required for impurity profiling

, &

References

  • Lunn, G.; Schmuff, N. R. HPLC Methods for Pharmaceutical Analysis, Vols. 1–4, New York : John Wiley, 1997–2000.
  • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline: Impurities in New Drug Substances Q3A(R2), step 5, http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html, 2006.
  • Warner, A.; Piraner, I.; Weimer, H.; White, K. Development of a Purity Control Strategy for Pemetrexed Disodium and Validation of Associated Analytical Methodology. J. Pharm. Biomed. Anal. 2015, 105, 46–54.
  • Reid, G. L.; Cheng, G.; Fortin, D. T.; Harwood, J. W.; Morgado, J. E.; Wang, J.; Xue, G. Reversed-Phase Liquid Chromatographic Method Development in an Analytical Quality by Design Framework. J. Liq. Chromatogr. Related Technol. 2013, 36, 2612–2638.
  • Wang, L.; Zheng, J.; Gong, X.; Hartman, R.; Antonucci, V. Efficient HPLC Method Development using Structure-Based Database Search, Physico-Chemical Prediction and Chromatographic Simulation. J. Pharm. Biomed. Anal. 2015, 104, 49–54.
  • Jayaraman, K.; Alexander, A. J.; Hu, A. Y.; Tomasella, F. P. A Stepwise Strategy Employing Automated Screening and DryLab Modeling for the Development of Robust Methods for Challenging High Performance Liquid Chromatography Separations: A Case Study. Anal. Chem. Acta, 2011, 696, 116–124.
  • Stafford, J. D.; Maloney, T. D.; Myers, D. P.; Cintron, J. M.; Castle, B. C. A Systematic Approach to Development of Liquid Chromatographic Impurity Methods for Pharmaceutical Analysis. J. Pharm. Biomed. Anal, 2011, 56, 280–292.
  • Biswas, K. M.; Castle, B. C.; Olsen, B. A.; Risley, D. S.; Skivic, M. J.; Wright, P. B. A Simple and Efficient Approach to Reversed-Phase HPLC Method Screening. J. Pharm. Biomed. Anal. 2009, 49, 692–701.
  • Hewitt, E. F.; Lukulay, P.; Galushko, S. Implementation of Rapid and Automated High Performance Liquid Chromatography Method Development Strategy for Pharmaceutical Drug Candidates. J. Chromatogra. A. 2006, 1107, 79–87.
  • Heyrman, A. N.; Henly, R. A. Importance of Controlling Mobile Phase pH in Reversed Phase HPLC. Keystone Technical Bulletin. 1999, TB 99–06.
  • Nelson, M. D.; Dolan, J. W. Gradient Background Peaks-A Case Study. LCGC. 1988, 16, 992–996.
  • Dumarey, M.; Sneyers, R.; Janssens, W.; Somers, I.; Heyden, Y. V. Drug Impurity Profiling: Method Optimization on Dissimilar Chromatographic Systems Part I: pH Optimization of the Aqueous phase. Anal. Chem. Acta. 2009, 656, 85–92.
  • Xue, G.; Bendick, A. D.; Chen, R.; Sekkulic, S. S. Automated Peak Tracking for Comprehensive Impurity Profiling in Orthogonal Liquid Chromatographic Separation using Mass Spectrometric Detection. J. Chromatogr. A. 2004, 1050, 159–171.
  • Karmarkar, S.; Garber, R.; Genchanok, Y.; George, S.; Yang, X.; Hammond, R. Quality by Design (QbD) Based Development of Stability Indicating HPLC Method for Drug and Impurities. J. Chrom. Sci. 2011, 49, 439–446.
  • Subirats, X.; Rosés, M.; Bosch, E. On the Effect of Organic Solvent Composition on the pH of Buffered HPLC Mobile Phases and the pKa of Analytes-A Review. Sep. Puri. Review. 2007, 36, 231–255.
  • LoBrutto, R.; Kazakevich, Y. Reversed-phase HPLC. HPLC Pharm. Sci. 2007, 139–239.
  • Espinosa, S.; Bosch, E.; Rosés, M. Retention of Ionizable Compounds on HPLC. 12. The Properties of Liquid Chromatography Buffers in Acetonitrile-Water Mobile Phase that Influence HPLC retention. Anal. Chem. 2002, 74, 3809–3818.
  • Zhang, K.; Li, Y.; Tsang, M.; Chetwyn, N. P. Analysis of Pharmaceutical Impurities using Multi-Heartcutting 2D LC Coupled with UV-Charged Aerosol MS Detection. J. Sep. Sci. 2013, 36, 2986–2992.
  • Chavali, A.; Wheat, T. E.; McConvile, P. R. Systematic Screening of pH and Ionic Strength as Method Development Tools for Reversed-Phase Separations. Pittcon 2013, Philadelphia, March 17–21, 2013.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.