Skip to main content
SpringerLink
Log in

LC Method for Studies on the Stability of Sibutramine in Soft Gelatin Capsules

  • Original
  • Published:
Chromatographia Aims and scope Submit manuscript

Abstract

A sensitive and rapid liquid chromatographic method was successfully developed and validated for the determination of sibutramine hydrochloride in bulk and capsules. Sibutramine in the presence of its degradation products was analyzed using UV detection at 225 nm. Chromatography was performed on a reversed-phase C8 (150 × 4.0 mm I.D., 5 μm) analytical column under isocratic conditions. The mobile phase was composed of acetonitrile:water (aqueous phase containing 0.3% triethylamine and pH adjusted to 7.0) (75:25, v/v) at a flow-rate of 1.1 mL min−1. No chromatographic interference was found during the analysis. Light was the stress condition which most contributed to sibutramine degradation. The method showed a linear response (r > 0.999) from 30 to 90 μg mL−1. The mean recovery for capsules was 101.2%. Inter-day assays showed relative standard deviations of 0.42 and 1.62% for bulk and capsules, respectively. The developed method is able to separate sibutramine from its major degradation products and it may be used in the quality control of this active pharmaceutical ingredient in both bulk and capsules.

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

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  1. James WPT, Astrup A, Finer N, Hilsted J, Kopelman P, Rössner S, Saris WHM, Gaal LFV (2000) Lancet 356:2119–2125. doi:10.1016/S0140-6736(00)03491-7

    Article  CAS  Google Scholar 

  2. Chaput JP, Tremblay A (2006) Eur J Clin Pharmacol 62:793–803. doi:10.1007/s00228-006-0186-z

    Article  Google Scholar 

  3. Bérubé-Parent S, Prud’homme D, St-Pierre S, Doucet E, Tremblay A (2001) Int J Obes 25:1144–1153. doi:10.1038/sj.ijo.0801677

    Article  Google Scholar 

  4. Shuh LM, Schuster CR, Hopper JA, Mendel CM (2000) Psychopharmacology (Berl) 147:339–346. doi:10.1007/s002130050001

    Article  Google Scholar 

  5. The United States Pharmacopeia 31st (2008) Rockville

  6. European Pharmacopoeia 6.2 (2008) Council of Europe

  7. Hind ID, Manghan JE, Ghani SP, Haddock RE, Garratt CJ, Jones RW (1999) Eur J Clin Pharmacol 54:847–849. doi:10.1007/s002280050565

    Article  CAS  Google Scholar 

  8. Chen J, Lu W, Zhang O, Jiang X (2003) J Chromatogr B Anal Technol Biomed Life Sci 785:197–203. doi:10.1016/S1570-0232(02)00818-8

    Article  CAS  Google Scholar 

  9. Ding L, Hao X, Huang X, Zhang S (2003) Anal Chim Acta 492:241–248. doi:10.1016/S0003-2670(03)00209-5

    Article  CAS  Google Scholar 

  10. Bhatt J, Shah B, Kambli S, Subbaiah G, Singh S, Ameta S (2007) J Chromatogr Sci 45(2):91–96

    CAS  Google Scholar 

  11. Segall AI, Collado EA, Ricci RA, Pizzorno MT (2003) J Liq Chromatogr Relat Technol 26(6):977–986. doi:10.1081/JLC-120018897

    Article  CAS  Google Scholar 

  12. Radhakrishna T, Narayana CL, Rao DS, Vyas K, Reddy GO (2000) J Pharm Biomed Anal 22:627–639. doi:10.1016/S0731-7085(99)00303-9

    Article  CAS  Google Scholar 

  13. Xiao SY, Liu Y, Chen H, Chen ZT, Xia ZN (2005) Chin J Anal Chem 33(12):1761–1763

    CAS  Google Scholar 

  14. ICH (2003) International conference on harmonization on stability testing of new drug substances and products. ICH, Geneva

    Google Scholar 

  15. Abbott (2006) Reductil. Rio de Janeiro

  16. FDA (1994) Center for drug evaluation and research. reviewer guidance: validation of chromatographic methods. Rockville, MD

  17. ICH (2005) International conference on harmonization on validation of analytical procedures: text and methodology

Download references

Acknowledgments

The authors would like to thank CNPq for the financial support of L.F.S. Martins.

Author information

Authors and Affiliations

  1. Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, UFRGS. Av. Ipiranga 2752, Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

    Letícia Flores da Silva Martins, Pedro Eduardo Froehlich & Ana Maria Bergold

Authors
  1. Letícia Flores da Silva Martins
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Pedro Eduardo Froehlich
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Ana Maria Bergold
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Letícia Flores da Silva Martins.

Additional information

Separation Analysis Applied to Pharmaceutical Sciences in Brazil.

Rights and permissions

Reprints and permissions

About this article

Cite this article

da Silva Martins, L.F., Froehlich, P.E. & Bergold, A.M. LC Method for Studies on the Stability of Sibutramine in Soft Gelatin Capsules. Chroma 69 (Suppl 2), 109–113 (2009). https://doi.org/10.1365/s10337-009-1018-y

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1365/s10337-009-1018-y

Keywords

Search

Navigation