Skip to main content
SpringerLink
Log in

Validation of HPLC Techniques for Pharmaceutical Analysis

  • Published:
Pharmaceutical Chemistry Journal Aims and scope

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

REFERENCES

  1. Int. Conf. on Harmonization (ICH), Text on Validation of Analytical Procedures(1994).

  2. Int. Conf. on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures, ICH-Q2A, Geneva (1995).

  3. Int. Conf. on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures: Methodology, ICH-Q2B, Geneva (1996).

  4. Reviewer Guidance: Validation of Chromatographic Methods. Center for Drug Evaluation and Research (CDER), Washington (1994).

  5. US FDA, General Principles of Validation, Center for Drug Evaluation and Research (CDER), Rockville, MD (1987).

    Google Scholar 

  6. US FDA, Guidelines for Submitting Samples and Analytical Data for Methods Validation, Center for Drugs and Biologies, Department of Health and Human Services, Rockville, MD (1987).

    Google Scholar 

  7. U. S. Pharmacopoeia. Validation of Compendial Methods, USP-26-NF21 (2003).

  8. USSR State Pharmacopoea(XIth Ed.) [in Russian], Moscow (1998), Vol. 1, pp. 200–220.

  9. T. O. Wilson, J. Pharm. Biomed. Anal., 8, 389–400 (1990).

    Google Scholar 

  10. P. A. D. Edwardson, G. Bhaskar, and J. E. Fairbrother, Pharm. Biomed. Anal., 8, 929–933 (1990).

    Google Scholar 

  11. J. Caporal-Gautier, J. M. Nfivet, P. Algranti, et al., Rapport d'une Commission SFSTP, STP Pharma Pratiques, No. 2, 205–239 (1992).

  12. H. Wegscheider, "Validation of analytical methods," in: Accreditation and Quality Assurance in Analytical Chemistry, H. Guenzler (ed.), Springer Verlag, Berlin (1996).

    Google Scholar 

  13. J. M. Green, A Practical Guide to Analytical Method Validation, Analytical Chemistry News & Features, May 1, 305A–309A (1996).

  14. Chemical Encyclopedia[in Russian], Moscow (1992), Vol. 3, pp. 72–74.

  15. Guidance for Industry. Analytical Procedures and Methods of Validation (Chemistry, Manufacturing, and Controls Documentation) Draft Guidance, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologies Evaluation and Research (CBER), Rockville, MD (2000).

  16. M. E. Swartz and I. S. Krull, Analytical Methods: Development and Validation, Marcel Dekker Inc., New York (1997).

    Google Scholar 

  17. L. Huber, BioPharm, 12, 64–66 (1999); L. Huber, Validation of Analytical Methods: Review and Strategy, LC-GC, 1997-1, Version February 21 (1999).

  18. L. Huber, Validation of Computerized Analytical Systems, Interpharm Press, Buffalo Grove, IL (1995).

    Google Scholar 

  19. L. Huber, Validation and Qualification in Analytical Laboratories, Interpharm Press, Buffalo Grove, IL (1998).

    Google Scholar 

  20. Validation of Analytical Methods and Tests[in Russian], Farmakom, No. 6, 44–58 (1999).

  21. Pharmeuropa. Technical Guide for the Elaboration of Monographs (3-rd Ed.), (1999), Ch. III, Analytical Validation.

  22. British Pharmacopoeia(2001), Vol. 11, Appendix III, A141-A144.

  23. R. J. Bopp, T. J. Wozniak, S. L. Anliker, and J. Palmer, "Development and validation of liquid chromatographic assays for the regulatory control of pharmaceuticals," in: Pharmaceutical and Biomedical Applications of Liquid Chromatography, Ch. 10, Riley C. M., Lough W. J., and Wainer I. W. (eds.), Elsevier-Pergamon (1994), pp. 315–344.

  24. G. C. Hokanson, part I: Pharm. Tech., Sept. (1994), pp. 118–130; part II: Pharm. Tech., Oct. (1994), pp. 92-100.

  25. Renger, H. Jehle, M. Fisher, and W. Funk, J. Planar Chrom., No. 8, 269–278 (1995).

  26. Development and Validation of Analytical Methods, Progress in Pharmaceutical and Biomedical Analysis, Vol. 3, C. M. Riley and T. W. Rosanske (eds.), Elsevier-Pergamon, Tarryton, NY (1996).

    Google Scholar 

  27. L. R. Snyder, J. J. Kirkland, and J. L. Glajch, Practical HPLC Method Development(2nd ed.), J. Wiley, New York (1997).

    Google Scholar 

  28. I. Krul and M. Swartz, Quantitation in Method Validation, LC-GC, 16(12), 1084–1090 (1998).

    Google Scholar 

  29. J. Adamovics, Chromatographic Analysis of Pharmaceuticals, Marcel Dekker, New York (1997).

    Google Scholar 

  30. U. D. Neue, HPLC Columns: Theory, Technology, and Practice(1997), pp. 334–337.

  31. W. B. Furman, J. G. Dorsey, and L. R. Snyder, Pharmaceutical Technology, 22(6), 58 (1998); W. B. Furman, J. G. Dorsey, and L. R. Snyder, System Suitability Tests in Regulatory Liquid and Gas Chromatographic Methods: Adjustments Versus Modifications, Discussion Paper in Internet, LC-GC (1999).

    Google Scholar 

  32. Y. Van der Heyden and D. L. Massart, "Review of the use of robustness and ruggedness in analytical chemistry," in: Robustness of Analytical Methods and Pharmaceutical Technological Products, A. Smilde, J. de Boerm and M. Hendriks (eds.), Elsevier, Amsterdam (1996), pp. 79–147.

    Google Scholar 

  33. A. Nijhuis, H. C. M. van der Knaap, S. de Jong, and B. G. M. Vandeginste, Anal. Chim. Acta, 391, 187–202 (1999).

    Google Scholar 

  34. Y. Van der Heyden, M. Jimidar, E. Hund, et al., J. Chromatogr. A, 845, 145–154 (1999).

    Google Scholar 

  35. K. Doerfel', Statistics in Analytical Chemistry[Russian translation], Mir, Moscow (1969), pp. 190–194; (1994), pp. 173-175.

    Google Scholar 

  36. S. Burke, LC-GC Europe Online Supplement. Statistics and Data Analysis(2002), pp. 13–18.

  37. R. I. Alekseev and Yu. I. Korovin, A Guide to Calculations and Processing of Results of Quantitative Analyses[in Russian], Atomizdat, Moscow (1972), p. 15.

    Google Scholar 

  38. N. A. Épshtein, Khim.-Farm. Zh., 36(12), 37–41 (2002).

    Google Scholar 

  39. A. K. Charyshev, Mathematical Processing of the Results of Chamical Analyses[in Russian], Khimiya, Leningrad (1984).

    Google Scholar 

  40. P. C. Meier and R. E. Zund, Statistical Methods in Analytical Chemistry, John Wiley & Sons, New York (2000).

    Google Scholar 

  41. N. A. Épshtein, Khim.-Farm. Zh., 36(11), 52–54 (2002).

    Google Scholar 

  42. R. Romero, D. Gazquez, and M. Sanchez-Vinas, LC-GC, 20(1), 72–80 (2002).

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. “Akrikhin” Chemico-Pharmaceutical Joint-Stock Company, Staraya Kupavna, Moscow Region, Russia

    N. A. Épshtein

Authors
  1. N. A. Épshtein
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Épshtein, N.A. Validation of HPLC Techniques for Pharmaceutical Analysis. Pharmaceutical Chemistry Journal 38, 212–228 (2004). https://doi.org/10.1023/B:PHAC.0000038422.27193.6c

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1023/B:PHAC.0000038422.27193.6c

Keywords

Search

Navigation