Validation of method for quantitative determination of phenobarbital in the sublingual tablet “Corvalol” at "Dissolution" test

Authors

  • Иларион Александрович Омельченко National University of Pharmacy Pushkinska str., 53, Kharkov, Ukraine, 61002 PJSC “Farmak” Frunze str., 63, Kyiv, Ukraine, 04080, Ukraine
  • Татьяна Григорьевна Ярных National University of Pharmacy Pushkinska str., 53, Kharkov, Ukraine, 61002, Ukraine
  • Геннадий Ильич Борщевский PJSC “Farmak” Frunze str., 63, Kyiv, Ukraine, 04080, Ukraine
  • Вадим Анатольевич Коноваленко PJSC “Farmak” Frunze str., 63, Kyiv, Ukraine, 04080, Ukraine

DOI:

https://doi.org/10.15587/2519-4852.2016.81301

Keywords:

validation, specificity, correctness, precision, robustness, chromatography, dissolution, Phenobarbital, sublingual tablets

Abstract

Validation of method for quantitative determination of Phenobarbital in the sublingual tablet “Corvalol” at “Dissolution” test was carried out by high performance liquid chromatography method.

Aim. To validate the method for quantitative determination of Phenobarbital at "Dissolution" test in accordance with the State Pharmacopoeia of Ukraine (SPhU) requirements; to prove by experimental research that the method allows reliably monitoring Phenobarbital content in the sublingual tablet “Corvalol”.

Methods. HPLC method was used for research in accordance with the SPhU requirements.

Results. The study of specificity criteria of method for Phenobarbital quantitative determination, its correctness, precision, linearity and robustness was carried out. It was determined, that the method meets the SPhU requirements on the main validation parameters. Results of research were used for development of methods for quality control of sublingual tablets “Corvalol”.

Conclusion. Validation of the method for quantitative determination of Phenobarbital in the remedy “Corvalol” sublingual tablets at "Dissolution" test in accordance with the State Pharmacopoeia of Ukraine (SPhU) requirements was carried out. It has been proven that the method meets the SPhU requirements on the specificity, correctness, precision, and robustness in the range of 60–120 % of the nominal content. The obtained data were used for development of methods for quality control of the remedy “Corvalol” sublingual tablets

Author Biographies

Иларион Александрович Омельченко, National University of Pharmacy Pushkinska str., 53, Kharkov, Ukraine, 61002 PJSC “Farmak” Frunze str., 63, Kyiv, Ukraine, 04080

Postgraduate student

Department of Drug Technology

Leading specialist

Laboratory of pharmaceutical medicines development of Biotechnology Department 

Татьяна Григорьевна Ярных, National University of Pharmacy Pushkinska str., 53, Kharkov, Ukraine, 61002

Doctor of pharmaceutical sciences, professor, Honored person of Science and Technology of Ukraine

Department of drug technology

Геннадий Ильич Борщевский, PJSC “Farmak” Frunze str., 63, Kyiv, Ukraine, 04080

Doctor of Pharmacy, Head of laboratory

Laboratory of pharmaceutical medicines development of Biotechnology Department 

Вадим Анатольевич Коноваленко, PJSC “Farmak” Frunze str., 63, Kyiv, Ukraine, 04080

Head of sector

Sector of Department of Biotechnology

References

  1. Seredinskaya, N. N., Borshevskaya, M. I., Mokhort, N. A., Kirichok, L. M. (2012). Corvalol: efficacy and safety are confirmed – mean life of the drug continues. Part I. The prospect of the creation of new dosage forms and the feasibility of their use (preclinical studies). Experimental and clinical medicine, 4, 22–29.
  2. Fu, Y., Yang, S., Jeong, S. H., Kimura, S., Park, K. (2004). Orally Fast Disintegrating Tablets: Developments, Technologies, Taste-Masking and Clinical Studies. Critical Reviews in Therapeutic Drug Carrier Systems, 21 (6), 433–476. doi: 10.1615/critrevtherdrugcarriersyst.v21.i6.10
  3. Nagar, P., K. Singh, I. Chauhan et. al. (2011). Orally disintegrating tablets : formulation, preparation techniques and evaluation. Journal of Applied Pharmaceutical Science, 01 (04), 35–45.
  4. Debjit, B., Chiranjib, B., Krishnakanth, R. et. al. (2009). Fast Dissolving Tablet: An Overview. Journal of Chemical and Pharmaceutical Research, 1 (1), 163–177.
  5. Abdelbary, G., Eouani, C., Prinderre, P., Joachim, J., Reynier, J., Piccerelle, P. (2005). Determination of the in vitro disintegration profile of rapidly disintegrating tablets and correlation with oral disintegration. International Journal of Pharmaceutics, 292 (1-2), 29–41. doi: 10.1016/j.ijpharm.2004.08.019
  6. Cirri, M., Rangoni, C., Maestrelli, F., Corti, G., Mura, P. (2005). Development of Fast-Dissolving Tablets of Flurbiprofen-Cyclodextrin Complexes. Drug Development and Industrial Pharmacy, 31 (7), 697–707. doi: 10.1080/03639040500253694
  7. Grizodub, A. I., Leontiev, D. A., Denisenko, N. V., Podpruzhnikov, Y. V. (2004). A standardized procedure for the validation of quantitative methods of analysis of drugs by standard. Farmakom, 3, 3–17.
  8. State Pharmacopoeia of Ukraine (2001). Kharkiv: RIREH, 556.
  9. Laboratory glassware. Graduated pipettes. Chep. 2. Graduated pipettes without a specific waiting time: GOST 29228-91 (1992). Moscow: Publishing House of Standards, 9.
  10. State Pharmacopoeia of Ukraine. Amendment 2 (2008). Kharkiv: State Enterprise “Scientific-expert Pharmacopoeia Center”, 620.

Downloads

Published

2016-10-30

How to Cite

Омельченко, И. А., Ярных, Т. Г., Борщевский, Г. И., & Коноваленко, В. А. (2016). Validation of method for quantitative determination of phenobarbital in the sublingual tablet “Corvalol” at "Dissolution" test. ScienceRise: Pharmaceutical Science, (3 (3), 32–37. https://doi.org/10.15587/2519-4852.2016.81301

Issue

No. 3 (3) (2016)

Section

Pharmaceutical Science

License

Copyright (c) 2016 Иларион Александрович Омельченко, Татьяна Григорьевна Ярных, Геннадий Ильич Борщевский, В. А. Коноваленко

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Our journal abides by the Creative Commons CC BY copyright rights and permissions for open access journals.