Validation of the spectrophotometric method of the determination of sildenafil citrate in tablet form

  • G.V. Anelchyk -
  • D.I. Alexandrova -
  • G.V. Maltsev -
  • A.V. Yegorova -
  • V.P. Antonovich -
  • ZA. Giher -
Keywords: spectrophotometry, sildenafil citrate, validation of analytical method, profiles of dissolution, an ionisation constant

Abstract

The express spectrophotometric method of quantitative determination of sildenafil citrate in ta­blets «Intagra» (JV «InterChem») has been developed and validated. Values of constants of ionisation sildenafil (pK1 = 3,66, pK2 = 5,17 and pK3 = 10,03) have been calculated. To confirm the bioequivalence by comparative researches in vitro the determination of dissolution profiles of the drug-generic «Intagra» (JV «InterChem) and a referent drug «Viagra» («Pfizer») in three media with values of pH 1,2; pH 4,5 and pH 6,8 has been spent. Values of factors of similarity f2 which values testify to equivalence of drugs have been calculated.

References

Grizodub AI // Pharmacom. - 2002 - № 3. - P. 42-50

Grizodub AI, Leontiev DA, Denisenko NI, Podpruzhnikov Yu.V. // Ibid. - 2004. - № 3. - P. 3—17.

Grizodub A.I. // Ibid. - 2006. - № 1-2. - P. 35-44.

State Pharmacopoeia of Ukraine. - X .: RIREG, 2001. - 556 p.

State Pharmacopoeia of Ukraine. - Extra. 1. - X .: RIREG, 2004. - 520 p.

State Pharmacopoeia of Ukraine. - Extra. 2. - X .: Pharmacopoeial Research Center, 2008. - 620 p.

Compendium 2006 - Medicinal Products / Edited by V.N. Kovalenko, A.P. Viktorova. - K .: MORION, 2006. - 2270 p.

Mashkovsky M.D. Medicines - 15th ed. - M .: New Wave, 2006. - 1206 p.

Rossotti F., Rossotti X. Determination of stability constants and other equilibrium constants in

solutions. - M .: Mir, 1965. - 564 p. ,.

Aboul-Enein N. Y .; M. M. Hefnawy // J. Liq. Chromatogr. & Rel. Technol. - 2003. - Vol. 26 No. 17. P. 2897-2908.

Anelchyk G., Yegorova A., Aleksandrova D. et al. // Book of abstracts 12th European Conference on the Spectroscopy of Biological Molecules. - Paris, France, 2007. - P. 311.

Dinesh N.D., Nagaraja P., Made Gowda N.M. et al. // Talanta. - 2002. - Vol. 57, 4. P. 757-764.

Goldstein I., Lue T.F., Padma-Nathan H. et al. / / New Engl. J. Med. - 1998. - Vol. 338, 20. P. 1397-1404.

Kuchekar B.S., Thakkar S.V., Chothe P.P. et al. / / Indian J. Pharm. Sci. - 2005. - Vol. 67, No. 6. - P.749-751.

Liu S.-R., Fan L, Hu Xi-L., Liu Z.-F., Li S. // Anal. Sci. - 2006. - Vol. 22, 6. P. 819-823.

Rao P. V., Vasu K., Sujatha S. et al. / / Asian J. Chem. - 2006. - Vol. 18, No. 4, P. 2475-2478.

Saad S.H., Stage M.E., Wagiha H.M. et al. // J. of Applied Electrochemistry - 2006 - Vol. 36 No. 2. P. 139-146.

Xiaolan Zhu, Song Xiao, Bo Chen, Fei Zhang et al. // J. Chromatogr. A. - 2005. - Vol. 1066. P. 89-95.

Published
2009-08-25
How to Cite
Anelchyk, G., Alexandrova, D., Maltsev, G., Yegorova, A., Antonovich, V., & Giher, Z. (2009). Validation of the spectrophotometric method of the determination of sildenafil citrate in tablet form. Farmatsevtychnyi Zhurnal, (4), 94-101. Retrieved from https://pharmj.org.ua/index.php/journal/article/view/965
Section
Original Articles