Skip to main content

Stability-Indicating UV-Spectrophotometric Assay of Diethylcarbamazine Citrate in Pharmaceuticals

Diethylcarbamazine citrate (DEC) is a piperazine anthelmintic agent indicated for the treatment of individual patients with lymphatic filariasis. Two simple and sensitive UV-spectrophotometric techniques have been developed and validated for the determination of this drug in bulk parent substance and tablets, based on the measurement of the absorbance of DEC solution either in 0.1M HCl at 210 nm (method A) or in 0.1M H2SO4 at 209 nm (method B). Beer’s law was obeyed over the concentration ranges of 1.25 – 25.0 and 2.5 – 30.0 μg · mL-1, for method Aand method B, respectively, and the corresponding molar absorptivity values were 2.02 × 104 and 1.21 × 104 L mol-1 · cm-1. The limits of detection (LOD) and quantification (LOQ) were, respectively, 0.26 and 0.78 μg · mL-1 (method A), and 0.16 and 0.49 μg · mL-1 (method B). These methods were assessed for intra-day and inter-day accuracy and precision, as well as robustness and ruggedness. Both methods were applied to one brand of tablets with percentage label claim of 101.7 and 100.8 for method A and method B, respectively, and the standard deviation was below 2%. In order to establish the stability-indicating ability of these methods, the drug was analyzed after subjecting it to acid and base hydrolysis, oxidation, heat and light stress conditions and the results indicated that the drug degraded extensively under both base- and oxidative-stress conditions, and remained intact under other stress conditions.

This is a preview of subscription content, access via your institution.

Fig. 1.
Fig. 2.
Fig. 3.
Fig. 4.
Fig. 5.
Fig. 6.
Fig. 7.
Fig. 8.

References

  1. World Health Organization (WHO), Lymphatic filariasis: The Disease and Its Control, Technical Reports Series, No. 821, WHO, Geneva (1992).

  2. E. A. Ottenson, The filariases and tropical eosinophilia, in K. S. Warren and A. D. F. Mahmoud (Eds.), Tropical and Geographical Medicine, 2 nd Edn., McGraw-Hill, New York (1990).

    Google Scholar 

  3. The British Pharmacopoeia, Her Majesty’s Stationery Office, London, England (1988), p. 190.

  4. United States Pharmacopoeia, Monograph USP30-NF25 (p. 1929), Pharmacopoeial Forum, 28, 1098.

  5. L. Bhanumathi, S. G. Wadodkar, and A. V. Kasture, Indian Drugs, 18(6), 204 – 206 (1981).

    CAS  Google Scholar 

  6. A. M. Wahbi, H. A. El-Obeid and E. A. Gad-Kariem, Farmaco Prat., 41(6), 210 – 214 (1986).

    PubMed  CAS  Google Scholar 

  7. M. Rizk, M. I. Walash, and F. Ibrahim, Spectr. Lett., 17(8), 423 – 440 (1984).

    Article  CAS  Google Scholar 

  8. U. A. Michael, C. O. Kenneth, and A. A. Anthony, Chem. Pharm. Bull., 47(4), 463 – 466 (1999).

    Article  Google Scholar 

  9. M. Ramachandran, Curr. Sci., 41(24), 890 – 891 (1972).

    CAS  Google Scholar 

  10. I. H. Refaat, M. E. El-Kommos, H. H. Farag, and N. A. El-Rabat, Bull. Pharm. Sci., Assiut Univ., 10(2), 85 – 102 (1987).

    CAS  Google Scholar 

  11. M. V. Bulbule, A. V. Kasture, and S. G. Wadodkar, Indian Drugs, 19(1), 27 – 28 (1981).

    CAS  Google Scholar 

  12. G. S. Bhuee, S. N. Rastogi, U. K. Jetley, and J. Singh, East. Pharm., 24(277), 197 – 198 (1981).

    CAS  Google Scholar 

  13. K. Basu and B. N. Dutta, Indian J. Pharm., 23, 326 – 329, (1961).

    CAS  Google Scholar 

  14. C. S. P. Sastry, M. Aruna, M. N. Reddy, and D. G. Sankar, Indian J. Pharm. Sci., 50(2), 140 – 142 (1988).

    CAS  Google Scholar 

  15. D. J. Vadodaria, M. N. Vora, and S. P. Mukherji, Indian J. Pharm., 30(2), 41 – 43 (1968)

    CAS  Google Scholar 

  16. K. N. Rao and D. Subrahmanyam, Indian J. Med. Res., 58(6), 746 – 752 (1970).

    PubMed  CAS  Google Scholar 

  17. N. Swamy, K. N. Prashanth, and K. Basavaiah, Inventi Impact: Pharm. Anal. Quality Assur., 2(2), 103 – 112 (2014).

    Google Scholar 

  18. W. Jezzy, D. B. Jaroszewski, A. Frank, et al., J. Pharm. Biomed. Anal., 14(5), 543 – 549 (1996).

    Article  Google Scholar 

  19. H. A. El-Obeid, Spectr. Lett., 17(6 – 7), 361 – 367 (1984).

    Article  CAS  Google Scholar 

  20. M. I. Walash, M. S. Rizk, and F. A. Ibrahim, J. Assoc. Off. Anal. Chem., 68(3), 532 – 534 (1985).

    PubMed  CAS  Google Scholar 

  21. G. R. Rao, S. Raghuveer, and P. Khadgapathi, Indian Drugs, 24(1), 37 – 41 (1986).

    CAS  Google Scholar 

  22. N. Mathew and M. Kalyanasundaram, Acta Trop., 80(2), 97 – 102 (2001).

    Article  PubMed  CAS  Google Scholar 

  23. D. Boopathy, D. Magham, B. Kumar, et al., Asian J. Res. Chem., 4(7), 1064 – 1066 (2011).

    Google Scholar 

  24. J. Mahesh Reddy, M. R. Jeyaprakash, K. Madhuri, et al., Indian J. Pharm. Sci., 73(3), 320–323 (2011).

    PubMed  PubMed Central  Google Scholar 

  25. M. B. Krishna Vamsi, R. Jayalakshmi, A. Vijay, and C. Sandeep, IJPSR, 3(9), 3347 – 3353 (2012).

    Google Scholar 

  26. B. Daravath, G. S. Reddy and S. K. Kamarapu, Asian J. Pharm. Clin. Res., 7(3), 98 – 102 (2014).

    Google Scholar 

  27. G. S. Reddy, B. Daravath, and S. K. Kamarapu, Int. J. Pharm. Bio. Sci., 3(4), 216 – 223 (2013).

    Google Scholar 

  28. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R 1), Complementary Guideline on Methodology, dated 06 November 1996, incorporated in November 2005, London.

  29. International Conference on Harmonization. Stability testing of new drug substances and products. International Conference on Harmonization, IFPMA, Geneva, Switzerland, 2003.

Download references

Acknowledgements

The authors are grateful to the quality control manager, Inga Laboratories Pvt. Ltd., Mumbai, India, for gift sample of pure diethylcarbamazine citrate and the authorities of the University of Mysore, Mysuru, for permission and facilities. Prof. K. Basavaiah thanks the University Grants Commission, New Delhi, India, for the award UGC-BSR Faculty Fellowship.From data in Figs. 48, it can be seen that the drug degraded extensively under base-hydrolysis and oxidative stress conditions, but remained stable under other stress conditions. These results are summarized in Table 6.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to K. Basavaiah.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Basavaiah, K., Swamy, N. Stability-Indicating UV-Spectrophotometric Assay of Diethylcarbamazine Citrate in Pharmaceuticals. Pharm Chem J 52, 271–277 (2018). https://doi.org/10.1007/s11094-018-1805-6

Download citation

  • Received:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11094-018-1805-6

Keywords

  • diethylcarbamazine citrate
  • assay
  • UV spectrophotometry
  • stability-indicating method