Skip to main content
SpringerLink
Log in

Application of HPLC mobile phase optimization methods to the detection of impurities in bulk drug steroids

  • Originals
  • Published:
Chromatographia Aims and scope Submit manuscript

Summary

Some mobile phase optimization methods have been used in developing a Reversed-Phase High-Performance Liquid Chromatography methodology for the determination of related impurities in bulk pharmaceutical steroids. Using two different approaches with binary and ternary mobile phase, the complete separation of 9-α-fluoroprednisolone acetate and its main potential impurities, at low concentration levels, has been achieved. This methodology may be applicable to other steroidal drugs and it is presented as an alternative to the thin-layer chromatography currently prescribed in official methods.

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

Similar content being viewed by others

References

  1. USP XXI, 7th Supp., p. 2858, The United States Pharmacopocial Convention, Inc., 1988.

  2. British Pharmacopoeia 1988, Her Majesty's Stationery Office, 1988.

  3. European Pharmacopoeia, 2nd Edition, Maissoneuve.

  4. T. M. Sokolova, A. P. Arzamastzer, G. J. Tygyntaer, N. K. Lerchenko, D. M. Osokin, J. Chromatogr.365, 137 (1986).

    Article  PubMed  Google Scholar 

  5. E. Ravinale, A. Rosso, J. Chromatogr.330, 415 (1985).

    Article  Google Scholar 

  6. Spanish Pat. No 520070, 525854, 528910, 529530, 529531.

  7. S. Gorog, “Quantitative Analysis of Steroids”, Elsevier, Amsterdam, 1983.

    Google Scholar 

  8. J. C. Berridge, “Techniques for the Automated Optimization of HPLC Separations”, Wiley Interscience, New York, 1985.

    Google Scholar 

  9. P. J. Schoenmakers, “Optimization of Chromatographic Selectivity” (Journal of Chromatography Library, Vol 35), Elsevier, Amsterdam, 1986.

    Google Scholar 

  10. J. W. Weyland, C. H. P. Bruins, D. A. Doornbos, J. Chrom Sci.22, 31 (1984).

    Google Scholar 

  11. M. A. Quarry, R. L. Grob, L. R. Snyder, J. W. Dolan, M. P. Rigney, J. Chromatogr.384, 163 (1987).

    Article  Google Scholar 

  12. M. Gazdag, G. Szepesi, E. Szeleczki, J. Chromatogr.454, 83 (1988).

    Article  PubMed  Google Scholar 

  13. A. K. Smilde, C. H. P. Bruins, D. A. Doornbos, J. Vink, J. Chromatogr.410, 1 (1987).

    Article  PubMed  Google Scholar 

  14. P. J. Schoenmakers, H. A. H. Billiet, L. de Galan, J. Chromatogr.282, 107 (1983).

    Article  Google Scholar 

  15. P. J. Schoenmakers, H. A. H. Billiet, L. de Galan, J. Chromatogr.218, 261 (1981).

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Departamento Control de Calidad, Cesquisa, Ap. 190. 40154, Perogordo, Segovia, (Spain)

    J. Martín Juárez & A. Bermejo

  2. Departamento Química Analítica, Facultad de Ciencias, Valladolid, (Spain)

    J. L. Bernal, Ma. J. del Nozal & G. A. García

Authors
  1. J. Martín Juárez
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. A. Bermejo
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. J. L. Bernal
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Ma. J. del Nozal
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. G. A. García
    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

Juárez, J.M., Bermejo, A., Bernal, J.L. et al. Application of HPLC mobile phase optimization methods to the detection of impurities in bulk drug steroids. Chromatographia 29, 338–346 (1990). https://doi.org/10.1007/BF02261300

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF02261300

Key Words

Search

Navigation