Skip to main content
SpringerLink
Log in

Development and Optimization of Stereoselective Liquid Chromatographic Method for Chiral Separation of (±)-cetirizine and Enantiopurity Assessment of R-levocetirizine

  • ARTICLES
  • Published:
Journal of Analytical Chemistry Aims and scope Submit manuscript

Abstract

R-levocetirizine, the racemic switch of (±)-cetirizine, is a potent H1-receptor antagonist. R-levocetirizine is currently marketed as oral dosage forms used to prevent and treat allergic conditions. In the present study, a stereoselective HPLC method was developed and optimized for the determination of cetirizine enantiomers in bulk and formulations by employing a chemometric tool. Chromatographic separation was carried out on a Chiralpak AS-3R analytical column (150 × 4.6 mm i.d., 3 µm). D-optimal mixture design was employed to study the effect of solvent composition, viz. acetonitrile (75–85%, v/v), MeOH (5–15%, v/v) and water (5–15%, v/v), by keeping other factors constant, such as mobile phase additives, flow rate (1.0 mL/min) and wavelength (235 nm) on output responses: retention factor and resolution of S- and R-enantiomers and analysis time. The mobile phase system comprising of acetonitrile−methanol−water−acetic acid−diethylamine (85 : 10 : 5 : 0.1 : 0.1, v/v) was selected as optimal by a graphical optimization trade-off technique. The proposed method was validated according to the ICH guidelines and successfully applied for the quantitation of cetirizine enantiomers in pharmaceutical dosage forms. The present study resulted in a fast and efficient liquid chromatographic method for the enantiopurity assessment of R-levocetirizine in real samples.

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. Nguyen, L.A., He, H., and Pham, H.C., Int. J. Biomed. Sci., 2006, vol. 2, p. 85.

    CAS  PubMed  PubMed Central  Google Scholar 

  2. Lees, P., Hunter, R.P., Reeves, P.T., and Toutain, P.L., J. Vet. Pharmacol. Ther., 2012, vol. 35, p. 17.

    Article  Google Scholar 

  3. Somogyi, A., Bochner, F., and Foster, D., Aust. Prescriber, 2004, vol. 27, p. 109.

    Article  Google Scholar 

  4. Valliappan, K. and Mannemala, S.S., J. Pharm. Biomed. Anal., 2016, vol. 120, p. 221.

    Article  Google Scholar 

  5. Criado, P.R., Jardim Criado, R.F., Maruta, C.W., and d’Apparecida Machado Filho, C., An. Bras. Dermatol., 2010, vol. 85, p. 195.

    Article  Google Scholar 

  6. Day, J.H., Ellis, A.K., and Rafeiro, E., Drugs Today, 2004, vol. 40, p. 415.

    Article  CAS  Google Scholar 

  7. Gillard, M., Van, D.P.C., Moguilevsky, N., Massingham, R., and Chatelain, P., Mol. Pharmacol., 2002, vol. 61, p. 391.

    Article  CAS  Google Scholar 

  8. Eom, H.Y., Kang, M., Kang, S.W., Kim, U., Suh, J.H., Kim, J., Cho, H.D., Jung, Y., Yang, D.H., and Han, S.B., J. Pharm. Biomed. Anal., 2016, vol. 117, p. 380.

    Article  CAS  Google Scholar 

  9. Mikus, P., Maráková, K., Valásková, I., and Havránek, E., Pharmazie, 2009, vol. 64, p. 423.

    CAS  PubMed  Google Scholar 

  10. Deng, X., Cock, D.B., Vervoort, R., Pamperin, D., Adams, E., and Schepdael, A.V., Chirality, 2012, vol. 24, p. 276.

    Article  CAS  Google Scholar 

  11. Gupta, A., Jansson, B., Chatelain, P., Massingham, R., and Udenaes, M.H., Rapid Commun. Mass Spectrom., 2005, vol. 19, p. 1749.

    Article  CAS  Google Scholar 

  12. Kang, S.W., Jang, H.J., Moore, V.S., Park, J.Y., Kim, K.A., Youm, J.R., and Han, S.B., J. Chromatogr. B: Anal. Technol. Biomed. Life Sci., 2010, vol. 878, p. 3351.

    Article  CAS  Google Scholar 

  13. Taha, E.A., Salama, N.N., and Wang, S., Drug Test Anal., 2009, vol. 1, p. 118.

    Article  CAS  Google Scholar 

  14. Gubitz, G. and Schmid, M.G., Biopharm. Drug Dispos., 2001, vol. 22, p. 291.

    Article  CAS  Google Scholar 

  15. Hu, Y.P., Song, Y.R., Wang, D.F., Yang, Y.P., Hou, D.Y., and Ouyang, J., Chin. J. Pharm. Anal., 2004, vol. 24, p. 289.

    CAS  Google Scholar 

  16. Choi, S.O., Lee, S.H., Kong, H.S., Kim, E.J., and Choo, H.Y., J. Chromatogr. B: Biomed. Sci. Appl., 2000, vol. 744, p. 201.

    Article  CAS  Google Scholar 

  17. Zhang, Z.F., Yang, G.L., Liang, G.J., Zhou, Y., and Chen, Y., Acta Pharm. Sin., 2004, vol. 39, p. 204.

    CAS  Google Scholar 

  18. Liu, Q., Zhang, Z., Bo, H., and Sheldon, R.A., Chromatographia, 2002, vol. 56, p. 233.

    Article  CAS  Google Scholar 

  19. Mannemala, S.S. and Valliappan, K., J. AOAC Int., 2015, vol. 98, p. 1769.

    Article  CAS  Google Scholar 

  20. Q2(R1) Validation of Analytical Procedures, Proc. Int. Conf. on Harmonization, Geneva: ICH, 2005.

  21. Chankvetadze, B., Methods Mol. Biol., 2013, vol. 970, p. 81.

    Article  CAS  Google Scholar 

  22. Scriba, G.K., J. Chromatogr. A, 2016, vol. 1467, p. 56.

    Article  CAS  Google Scholar 

  23. Scriba, G.K., Methods Mol. Biol., 2013, vol. 970, p. 1.

    Article  CAS  Google Scholar 

  24. Jibuti, G., Mskhiladze, A., Takaishvili, N., Karchkhadze, M., Chankvetadze, L., Farkas, T., and Chankvetadze, B., J. Sep. Sci., 2012, vol. 35, p. 2529.

    Article  CAS  Google Scholar 

  25. Gogaladze, K., Chankvetadze, L., Tsintsadze, M., Farkas, T., and Chankvetadze, B., Chirality, 2015, vol. 27, p. 228.

    Article  CAS  Google Scholar 

  26. Mosiashvili, L., Chankvetadze, L., Farkas, T., and Chankvetadze, B., J. Chromatogr. A, 2013, vol. 1317, p. 167.

    Article  CAS  Google Scholar 

  27. Valliappan, K. and Mannemala, S.S., Chromatographia, 2014, vol. 77, p. 1203.

    Article  Google Scholar 

  28. Valliappan, K. and Selvakumar, K., Chromatographia, 2017, vol. 80, p. 229.

    Article  Google Scholar 

  29. Hibbert, D.B., J. Chromatogr. B: Anal. Technol. Biomed. Life Sci., 2012, vol. 910, p. 2.

    Article  CAS  Google Scholar 

Download references

Funding

The author is grateful to UGC-SAP DRS Phase-II sponsored Department of Pharmacy, Annamalai University, Tamil Nadu, India, UGC Major research project [MRP-MAJOR-BIOT-2013-39967] for providing the facilities to carry this research work and also for the financial assistance through UGC-BSR fellowship.

Author information

Authors and Affiliations

  1. Department of Pharmacy, Faculty of Engineering and Technology, Annamalai University, 608002, Annamalai Nagar, Tamil Nadu, India

    Valliappan Kannappan

  2. Department of Pharmacy, Faculty of Engineering and Technology, Annamalai University, 608002, Annamalai Nagar, Tamil Nadu, India

    Selvakumar Kanthiah

Authors
  1. Valliappan Kannappan
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Selvakumar Kanthiah
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Valliappan Kannappan.

Ethics declarations

The authors declare no conflict of interest.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Valliappan Kannappan, Selvakumar Kanthiah Development and Optimization of Stereoselective Liquid Chromatographic Method for Chiral Separation of (±)-cetirizine and Enantiopurity Assessment of R-levocetirizine. J Anal Chem 75, 349–357 (2020). https://doi.org/10.1134/S1061934820030090

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1134/S1061934820030090

Keywords:

Search

Navigation