Skip to main content
Log in

Development and Validation of Stability-Indicating HPLC Method for the Quantification of Levetiracetam in Bulk and Oral Solution: Application to Chemical Kinetics

  • Published:
Pharmaceutical Chemistry Journal Aims and scope

In the present study, a simple, accurate, precise and specific stability-indicating LC method was developed and validated for the quantification of levetiracetam (LEV) in bulk and oral solution. LEV and its degradation products were separated and resolved successfully on C18 column using a methanol:water (30:70 %, v/v) mixture in the isocratic mode at a flow rate of 1 mL/min. All eluents were detected at 205 nm. In forced degradation experiments, LEV was found to degrade significantly in acid, alkali, wet heat, peroxide mediated oxidation, and photolytic conditions, and found stable under dry heat conditions. Validation experiments showed acceptable accuracy, precision, and specificity of the developed method. Assay of the oral solution was in good agreement with the amount of LEV as per the label claim. The method was applied to investigate chemical kinetics under acid and alkali hydrolysis and the pH rate profile of LEV within a range of pH 2 – 12.

This is a preview of subscription content, log in via an institution to check access.

Access this article

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.
Fig. 5.
Fig. 6.
Fig. 7.

Similar content being viewed by others

References

  1. M. Blessy, R. D. Patel, P. N. Prajapati, and Y. K. Agrawal, J. Pharm Anal., 4(3), 159 – 165 (2014).

    Article  CAS  Google Scholar 

  2. L. V. Allen, Jr. and L. A. Lawson, Remington: The Science and Practice of Pharmacy, London – Philadelphia: Pharmaceutical Press (2013), p. 665.

  3. A. N. Martin, Martin’s Physical Pharmacy and Pharmaceutical Sciences: Physical, Chemical and Biopharmaceutical Principles in Pharmaceutical Sciences, Lippincott Williams & Wilkins (2006), p. 318.

    Google Scholar 

  4. M. J. O’Neil, The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 14th ed., NJ USA (2006), p. 5461.

  5. M. Dooley and G. L. Plosker, Drugs, 60(4), 871 – 893 (2000).

    Article  CAS  Google Scholar 

  6. K. A. Lyseng-Williamson, Drugs, 71(4), 489 – 514 (2011).

    CAS  PubMed  Google Scholar 

  7. M. Bialer, S. I. Johannessen, H. J. Kupferberg, et al., Epilepsy Res., 61(1 – 3), 1 – 48 (2004).

    Article  Google Scholar 

  8. P. Nagaraju, G. I. Priyadarshini, and S. Appaji, Int. J. Pharm. Chem. Sci., 3(2), 522 – 527 (2014).

    Google Scholar 

  9. P. Ravishankar, A. Niharika, and P. Srinivasa Babu, Int. Res. J. Pharm., 6(8), 537 – 543 (2015).

    Article  Google Scholar 

  10. J. S. Shah, G. Vidyasagar, and H. Barot, Pharm. Sin., 3(5), 576 – 589 (2012).

    CAS  Google Scholar 

  11. K. M. Chaitanya Prasad, G. Vidyasagar and P. Sudhakar, Indian J. Pharm. Biol. Res., 1(4), 45 – 54 (2013).

    Article  Google Scholar 

  12. P. Patel, M. M. Patel, K. D. Raskapur and R. S. Mehta, J. Pharm. Res., 4(12), 4495 – 4497 (2011).

    Google Scholar 

  13. S. V. Gandhi, A. A. Kadam and M. M. Karad, Int. J. Pharm. Pharm. Sci., 6(5), 121 – 125 (2014).

    Google Scholar 

  14. A. E. El-Gendy, M. A. Mohamed, O. A. El-Aziz, et al., Anal. Chem. Indian J., 10(4), 264 – 271 (2011).

    CAS  Google Scholar 

  15. G. K. Alcantara, L. A. Calixto, L. A. de Moraes, et al., J. Anal. Meth. Chem., Article ID 5976324 (2016).

  16. J. Dupouey, N. Doudka, S. Belo, et al., Biomed. Chromatogr., 30(12), 2053 – 2060 (2016).

    Article  CAS  Google Scholar 

  17. M. V. Ramprasad and S. B. Sundar, Int. J. Sci. Eng. Res., 5(3), 602 – 609 (2014).

    Google Scholar 

  18. ICH Guidelines Q1A (R2), Stability Testing of New Drug Substances and Products.

  19. C. Mongay and V. A. Cerda, Annali Chim.., 64, 409 – 412 (1974).

    CAS  Google Scholar 

  20. ICH Guidelines Q2 (R1), Validation of Analytical Procedures: Text and Methodology.

Download references

Acknowledgements

The authors are grateful to the management and trustees of Mumbai Educational Trust for providing necessary analytical facilities to conduct this work and to Lupin Pharmaceuticals Ltd., Palghar, India, for providing gift sample of LEV.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Sandeep S. Sonawane.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Sonawane, S.S., Chhajed, S.S., Jadhav, D.R. et al. Development and Validation of Stability-Indicating HPLC Method for the Quantification of Levetiracetam in Bulk and Oral Solution: Application to Chemical Kinetics. Pharm Chem J 54, 870–876 (2020). https://doi.org/10.1007/s11094-020-02290-z

Download citation

  • Received:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11094-020-02290-z

Keywords

Navigation