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

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