Skip to main content
SpringerLink
Log in

Development and validation of an ultra-fast liquid chromatographic method for the quality control of famotidine formulations using a short monolithic stationary phase

  • Research Article
  • Published:
Central European Journal of Chemistry

Abstract

An HPLC method for the quality control of famotidine (FMT) containing formulations has been developed and validated. The combination of a short monolithic column (Chromolith® RP-18e 50 × 4.6 mm i.d.) and an elevated flow rate (3.0 mL min−1) enabled the proposal of a high-throughput analytical scheme capable of reliable operation in a demanding industrial environment. Detection was carried out at 265 nm. Thorough validation of the method included linearity (5–150%), limits of detection (0.13%) and quantification (0.41%), selectivity, precision (within- and day-to-day), accuracy and ruggedness. The new method was applied successfully to the analysis of samples (assay, dissolution, dosage & blending uniformity) during the production of four validation batches of FMT-containing tablets.

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. T. J. Humphries, Scand. J. Gastroenterol. 22, 55 (1987)

    Article  Google Scholar 

  2. B. Simon, P. Muller, H.G. Dammann, Innere Medizin 11, 81 (1984)

    Google Scholar 

  3. T.J. Humphries and G.J. Merritt, Aliment. Pharmacol. Ther. 13, 18 (1999)

    Article  CAS  Google Scholar 

  4. P.D. Tzanavaras, D.G. Themelis, Anal. Chim. Acta 588, 1 (2007)

    Article  CAS  Google Scholar 

  5. D. Guillarme, D.T.T. Nguyen, S. Rudaz, J-L. Veuthey, Eur. J. Pharm. Biopharm. 68, 430 (2008)

    Article  CAS  Google Scholar 

  6. M.E. Swartz, J. Liq. Chromatogr. Relat. Technol. 28, 1253 (2005)

    Article  CAS  Google Scholar 

  7. M.W. Dong, LC-GC North America 25, 656 (2007)

    CAS  Google Scholar 

  8. K. Cabrera, D. Lubda, H-M. Eggenweiler, H. Minakuchi, K. Nakanishi, J. High Resolut. Chromatogr. 23, 93 (2000)

    Article  CAS  Google Scholar 

  9. C.K. Zacharis, J. Chromatogr. Sci. 47, 443 (2009)

    CAS  Google Scholar 

  10. R. Isono, H. Kurokawa, N. Suzaki, M. Tomida, S. Kadil, T. Yamaguchi, Y. Fujita, Bunseki Kagaku 58, 715 (2009)

    Article  CAS  Google Scholar 

  11. M.I. Walash, A. El-Brashy, N. El-Enany, M.E. Kamel, J. Fruoresc. 19, 333 (2009)

    Article  CAS  Google Scholar 

  12. I.A. Darwish, S.A. Hussein, A.M. Mahmoud, A.I. Hassan, Spectrochim. Acta A 69, 33 (2008)

    Article  Google Scholar 

  13. M.I. Walash, M.K. Sharaf-El-Din, M. El-Sayed Metwally, M.R. Shabana, J. Chin. Chem. Soc. (Taipei) 52, 71 (2005)

    CAS  Google Scholar 

  14. Z. Korićanac T. Jovanović, J. Petković, D. Minić, J. Serb. Chem. Soc. 69, 485 (2004)

    Article  Google Scholar 

  15. M.S. Elazazy, A. Shalaby, M.N. Elbolkiny, H.M. Khalil, Chin. Pharm. J. 55, 481 (2003)

    CAS  Google Scholar 

  16. M.M. Ayad, A. Shalaby, H.E. Abdellatef, M.M. Hosny, Anal. Bioanal. Chem. 376, 710 (2003)

    Article  CAS  Google Scholar 

  17. N. Rahman, M. Kashif, Anal. Sci. 19, 907 (2003)

    Article  CAS  Google Scholar 

  18. N. Helali, N.T. Tran, L. Monser, M. Taverna, Talanta 74, 694 (2008)

    Article  CAS  Google Scholar 

  19. T. Perez-Ruiz, C. Martinez-Lozano, V. Tomas, E. Bravo, R. Galera, J. Pharm. Biomed. Anal. 30, 1055 (2002)

    Article  CAS  Google Scholar 

  20. N. Helali, L. Monser, J. Sep. Sci. 31, 276 (2008)

    Article  CAS  Google Scholar 

  21. N. Helali, F. Darghouth, L. Monser, Chromatographia 60, 455 (2004)

    Article  CAS  Google Scholar 

  22. C. Ho, H-M. Huang, S-Y. Hsu, C-Y. Shaw, B-L. Chang, Drug Dev. Ind. Pharm. 25, 379 (1999)

    Article  CAS  Google Scholar 

  23. A. Zarghi, A. Shafaati, S.M. Foroutan, A. Khoddam, J. Pharm. Biomed. Anal. 39, 677 (2005)

    Article  CAS  Google Scholar 

  24. United States Pharmacopoeia, USP30-NF25 2112 (2007)

  25. S.L. Rivera, S. Ghodbane, Int. J. Pharm. 108, 31 (1994)

    Article  CAS  Google Scholar 

  26. S. Wanwimolruk, A.R. Zoest, S.Z. Wanwimolruk, C.T. Hung, J. Chromatogr. B 572, 227 (1991)

    Article  CAS  Google Scholar 

  27. P.D. Tzanavaras, D.G. Themelis, Anal. Chim. Acta 581, 89 (2007)

    Article  CAS  Google Scholar 

  28. Food and Drug Administration: Guidance for Industry. Dissolution Testing of Immediate Release Solid Oral Dosage Forms (US Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research, Rockville MD, 1997)

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Laboratory of Analytical Chemistry, Department of Chemistry, Aristotle University of Thessaloniki, GR-54124, Thessaloniki, Greece

    Paraskevas D. Tzanavaras

Authors
  1. Paraskevas D. Tzanavaras
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Paraskevas D. Tzanavaras.

About this article

Cite this article

Tzanavaras, P.D. Development and validation of an ultra-fast liquid chromatographic method for the quality control of famotidine formulations using a short monolithic stationary phase. cent.eur.j.chem. 9, 446–452 (2011). https://doi.org/10.2478/s11532-011-0022-x

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2478/s11532-011-0022-x

Keywords

Search

Navigation