Abstract
A procedure for the quantitative HPLC determination of sodium metamizole is developed and validated to study dissolution profiles of the PENTALGIN IC® medicinal preparation, tablets, taking into account the decomposition of sodium metamizole in aqueous solutions. In the study of dissolution profiles, along with the release of sodium metamizole from the finished dosage form, its hydrolysis to the decomposition product, methylaminophenazone, occurs. The decomposition reaction is unimolecular; therefore, the chromatograms of the test and reference solutions have two peaks, corresponding to metamizole and methylaminophenazone. It is shown that, for the correct calculation of the amount of sodium metamizole passed to the solution from the tablet, one should determine it from the sum of areas of both peaks, taking into account detector response factors.
Similar content being viewed by others
REFERENCES
U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System, 2017. www.fda.gov/downloads/Drugs/Guidance. Accessed December 26, 2017.
Medina, J.R., Salazar, D.K., Hurtado, M., Cortes, A.R., and Domínguez-Ramírez, A.M., Saudi Pharm. J., 2014, vol. 22, p. 141. https://doi.org/10.1016/j.jsps.2013.02.001
Hassouna, M.E.M., Issa, Y.M., and Zayed, A.G., J. Appl. Pharm. Sci., 2012, vol. 2, no. 5, p. 52.https://doi.org/10.7324/JAPS.2012.2531
Shamal’, L.L., Shokhin, I.E., Yarushok, T.A., and Savchenko, A.Yu., Razrab. Regist. Lek. Sredstv. 2012, vol. 2, no. 3, p. 54.
Shokhin, I.E., Ramenskaya, G.V., Vasilenko, G.F., and Malashenko, E.A., Pharm. Chem. J., 2011, vol. 45, no. 2, p. 107.
Guidance on the Investigation of Bioequivalence, European Medicines Agency (EMA), Committee for Medicinal Products of Human Use (CHMP), 2010.
Mkrtchyan, M.A., Uch. Zap. Erevan. Gos. Univ., 2010, vol. 2, p. 24.
Golubitskii, G.B., Kosparnoi, A.V., Budko, E.V., Ivanov, V.M., and Basova, E.M., J. Anal. Chem., 2006, vol. 61, no. 10, p. 997.
Golubitskii, G.B., Budko, E.V., and Ivanov, V.M., J. Anal. Chem., 2006, vol. 61, p. 350.
Golubitskii, G.B., Basova, E.M., and Ivanov, V.M., J. Anal. Chem., 2008, vol. 63, no. 3, p. 253.
Giordani, M.A. and de Melo, E.B., Rev. Cienc. Farm. Basica Apl., 2012, vol. 33, no. 3, p. 347.
Derzhavna Farmakopeya Ukraini (State Pharmacopoeia of Ukraine), Kharkiv: Nauk.-Eksp. Farm. Tsentr", 2008.
Melent’eva, G.A., Farmatsevticheskaya khimiya (Pharmaceutical Chemistry), Moscow: Meditsina, 1976, p. 398.
Author information
Authors and Affiliations
Corresponding author
Additional information
Translated by V. Kudrinskaya
Rights and permissions
About this article
Cite this article
Yegorova, A.V., Mal’tsev, G.V., Skripinets, Y.V. et al. Determination of Sodium Metamizole by High Performance Liquid Chromatography Taking into Account its Decomposition in Aqueous Solutions in the Study of Dissolution Profiles. J Anal Chem 76, 486–492 (2021). https://doi.org/10.1134/S1061934821020052
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1134/S1061934821020052