Skip to main content
SpringerLink
Log in

Development of a Quantitative Determination Method for Polysorbate 80 in Biologicals by Size-Exclusion High-Performance Liquid Chromatography

  • Published:
Pharmaceutical Chemistry Journal Aims and scope

Aquantitative determination method for polysorbate 80 in biological medicinal preparations using size-exclusion chromatography with UV detection was developed. OASIS HLB solid-phase extraction cartridges were used to extract polysorbate 80 from formulations with high protein concentrations. The HPLC separation was performed using a TSKgel G2000SWX column in isocratic mode. The mobile phase was phosphate buffer (0.1 M) containing sodium sulfate (0.1 M) and sodium dodecyl sulfate (0.1%). The developed method could be used for quantitative determination of polysorbate 80 in biological medicinal products.

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.

Similar content being viewed by others

References

  1. T. Osterberg, A. Fatouros, and M. Mikaelsson, Pharm. Res., 14(7), 892 – 898 (1997).

    Article  CAS  PubMed  Google Scholar 

  2. A. Fatouros and B. Sjostrom, Int. J. Pharm., 194, 69 – 79 (2000).

    Article  CAS  PubMed  Google Scholar 

  3. M. Adamo, L. W. Dick, Jr., D. Qiu, et al., J. Chromatogr. B: Anal. Technol. Biomed. Life Sci., 878(21), 1865 – 1870 (2010).

  4. D. Ilko, A. Braun, O. Germershaus, et al., Eur. J. Pharm. Biopharm., 94, 569 – 574 (2015).

    Article  CAS  PubMed  Google Scholar 

  5. A. Christiansen, T. Backensfeld, S. Kuhn, and W. Weitschies, Pharmazie, 66(9), 666 – 671 (2011).

    CAS  PubMed  Google Scholar 

  6. J. Puschmann, D. H. Evers, C. C. Muller-Goymann, et al., J. Chromatogr. A, 1599, 136 – 143 (2019).

    Article  CAS  PubMed  Google Scholar 

  7. M. B. Degterev, R. A. Badaukayte, and R. R. Shukurov, J. Chromatogr. B: Anal. Technol. Biomed. Life Sci., 1133, 121847 (2019).

    Article  CAS  Google Scholar 

  8. N. Shende, A. Karale, S. Bhagade, et al., J. Pharm. Biomed. Anal., 18310 (2020).

  9. L. M. Nair, N. V. Stephens, and S. Vincent, J. Chromatogr. A, 1012(1), 81 – 86 (2003).

    Article  CAS  PubMed  Google Scholar 

  10. R. Zhang, Y. Wang, L. Tan, et al., J. Chromatogr. Sci., 50(7), 598 – 607 (2012).

    Article  CAS  PubMed  Google Scholar 

  11. T. Tani, J. M. Moore, and T. W. Patapoff, J. Chromatogr. A, 786(1), 99 – 106 (1997).

    Article  CAS  Google Scholar 

  12. S. Shi, Z. Chen, J. M. Rizzo, et al., J. Anal. Bioanal. Tech., 6(3), 245 – 247 (2015).

    Google Scholar 

  13. S. Fekete, K. Ganzler, and J. Fekete, J. Pharm. Biomed. Anal., 52(5), 672 – 679 (2010).

    Article  CAS  PubMed  Google Scholar 

  14. J. Pan, Y. Ji, Z. Du, and J. Zhang, J. Chromatogr. A, 1465, 190 – 196 (2016).

    Article  CAS  PubMed  Google Scholar 

  15. J. Kim and J. Qiu, Anal. Chim. Acta, 806, 144 – 151 (2014).

    Article  CAS  PubMed  Google Scholar 

  16. N. Savjani, E. Babcock, H. K. Khor, and A. Raghani, Talanta, 130, 542 – 546 (2014).

    Article  CAS  PubMed  Google Scholar 

  17. D. L. McKean, A. J. Pesce, and W. Koo, Anal. Biochim., 161(2), 348 – 351 (1987).

    Article  CAS  Google Scholar 

  18. ICH Harmonised Tripartite Guideline, Validation of analytical procedures: text and methodology Q2(R1); http://www.ema.europa.eu/docs/enGB/documents/Scientific-guideline/2006/ [https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf].

Download references

Author information

Authors and Affiliations

  1. Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051, Russia

    O. B. Rounova, M. G. Korotkov & O. B. Ustinnikova

Authors
  1. O. B. Rounova
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. M. G. Korotkov
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. O. B. Ustinnikova
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to O. B. Rounova.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 57, No. 11, pp. 59 – 64, November, 2023.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Rounova, O.B., Korotkov, M.G. & Ustinnikova, O.B. Development of a Quantitative Determination Method for Polysorbate 80 in Biologicals by Size-Exclusion High-Performance Liquid Chromatography. Pharm Chem J 57, 2013–2018 (2024). https://doi.org/10.1007/s11094-024-03110-4

Download citation

  • Received:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11094-024-03110-4

Keywords

Search

Navigation