Pharmaceutical Chemistry Journal

, Volume 42, Issue 11, pp 637–643 | Cite as

Requirements to HPLC systems suitable for quality control of parent substances and dosage forms

  • N. A. Epshtein
  • S. V. Emshanova
Structure of Chemical Compounds, Methods of Analysis and Process Control

The criteria (characteristics and their permissible values) for estimating the suitability of a chromatographic system intended for HPLC quality control of parent drugs and dosage forms are considered. Practical recommendations concering the HPLC system suitability criteria are formulated.


Dosage Form Ketoprofen Active Pharmaceutical Ingredient Relative Retention Time Main Compound 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Reviewer Guidance: Validation of Chromatographic Methods, Center for Drug Evaluation and Research (CDER), Washington (1994).Google Scholar
  2. 2.
    International Conference on Harmonization (ICH). Validation of Analytical Procedures: Text and Methodology, ICH, Q2(R1) (2005).Google Scholar
  3. 3.
    Eur. Pharmacopoeia (2007).Google Scholar
  4. 4.
    U. S. Pharmacopoeia. USP30-NF25 (2007).Google Scholar
  5. 5.
    Brit. Pharmacopoeia (2007).Google Scholar
  6. 6.
    L. R. Snyder, J. J. Kirkland, and J. L. Glajch, Practical HPLC Method Development, 2nd Ed., J. Wiley, New York (1997).Google Scholar
  7. 7.
    W. B. Furman, J. G. Dorsey, and L. R. Snyder, Pharm. Technol., 22(6), 58 (1998).Google Scholar
  8. 8.
    N. A. Epshtein, Khim.-farm. Zh., 38(4), 40–56 (2004).Google Scholar
  9. 9.
    J. Coleman, T. Wrzosek, R. Roman, et al., J. Chromatogr. A, 917, 23–27 (2001).PubMedCrossRefGoogle Scholar
  10. 10.
    M. Dong, R. Paul, and L. Gershanov, Getting the Peaks Perfect: System Suitability for HPLC, Today’s Chemist at Work (2001).Google Scholar
  11. 11.
    J. W. Dolan, System Suitability, LC-GC, 22(5), 432–435 (2004).Google Scholar
  12. 12.
    Method Validation in Pharmaceutical Analysis. A Guide to Best Practice, J. Ermer and J. H. McB. Miller, eds., Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim (2005).Google Scholar
  13. 13.
    Y. Vander Heyden and D. L. Massart, in: Robustness of Analytical Methods and Pharmaceutical Technological Products, A. Smilde, J. de Boer, and M. Hendriks, eds., Elsevier, Amsterdam (196), pp. 79–147.Google Scholar
  14. 14.
    A. Nijhuis, H. C. M. van der Kamp, S. de Jong, and B. G. M. Vandeginste, Anal. Chim. Acta, 391, 187–202 (1999).CrossRefGoogle Scholar
  15. 15.
    Y. van der Heyden, M. Jimidar, E. Hund, et al., J. Chromatogr. A, 845, 145–154 (1999).CrossRefGoogle Scholar
  16. 16.
    E. Hund, Y. Vander Heyden, M. Haustein, et al., J. Chromatogr. A, 874, 167–185 (2000).PubMedCrossRefGoogle Scholar
  17. 17.
    Technical Guide, 4th Ed., Eur. Pharmacopoeia (2005).Google Scholar

Copyright information

© Springer Science+Business Media, Inc. 2008

Authors and Affiliations

  • N. A. Epshtein
    • 1
  • S. V. Emshanova
    • 1
  1. 1.Akrikhin Joint-Stock Company, Staraya KupavnaMoscow OblastRussia

Personalised recommendations