Development and validation of a dissolution method for ritonavir soft  gelatin capsules using UV-derivative spectroscopy

Rochele Cassanta Rossi; Patrícia Weimer; Josué Guilherme  Lisbôa Moura; Letícia Lenz Sfair; Pedro E. Fröehlich

doi:10.22481/exon.v10i2.20477

Autores

Rochele Cassanta Rossi Universidade Federal do Rio Grande do Sul
Patrícia Weimer Universidade Federal do Rio Grande do Sul
Josué Guilherme Lisbôa Moura Universidade do Vale do Rio dos Sinos
Letícia Lenz Sfair Universidade do Vale do Rio dos Sinos
Pedro E. Fröehlich Universidade Federal do Rio Grande do Sul

DOI:

https://doi.org/10.22481/exon.v10i2.20477

Palavras-chave:

Ritonavir, Dissolution, UV-derivative spectroscopy

Resumo

The aim of this work was to develop and validate a UV-derivative spectroscopic assay (UV-D) to evaluate the dissolution profile of ritonavir softgel capsules. The analytical performance characteristics of the proposed UV-D method were evaluated comparing with previously reported HPLC method. The linear dynamic range was 5.0-100.0 μg ml-1 with a correlation coefficient (r) > 0.999, the mean intra- and inter-assay relative standard deviation were lower than 3.3 and 2.8, respectively, and the mean recoveries were between 95.1-104.7%. The assay data obtained for LC and spectroscopic method showed non-significant difference at the confidence level of 95% (P= 0.05). The dissolution profiles obtained were compared using difference factor (f1) and similarity factor (f2) and demonstrated that the profiles obtained were similar (f1=12.4 / f2= 59.0). The UV-D assay developed is usefull to evaluate the dissolution profile of RTV soft gelatin capsules and for analysis routine, being an alternative to the LC method, being faster, simpler and using fewer solvents.

Downloads

Não há dados estatísticos.

Referências

Brunton, L. et al., 2017. Goodman and Gilman, The Pharmacological Basis of Therapeutics, thirteenth ed. McGraw-Hill, New York.

Goldfarb, N.E., Dunn, B.M., 2013. Human Immunodeficiency Virus 1 Retropepsin. Handbook Of Proteolytic Enzymes, p.190-199. Elsevier. http://dx.doi.org/10.1016/b978-0-12-382219-2.00044-2.

Hossain, M.A. et al, 2017. Inhibition of human cytochromes P450 in vitro by ritonavir and cobicistat. J. Pharm Pharmacol. 69(12), 1786-1793. http://dx.doi.org/10.1111/jphp.12820.

Page, M., Taylor, S., 2018. Antiretroviral Pharmacology. Medicine. 46(5), 287-292. http://dx.doi.org/10.1016/j.mpmed.2018.02.006.

AbbVie Inc., 2018. North Chicago, USA. NORVIR®. https://norvir.com/ (access on June 29, 2018).

Gupta, S. et al., 2013. Formulation Strategies to Improve the Bioavailability of Poorly Absorbed Drugs with Special Emphasis on Self-Emulsifying Systems. ISRN Pharm. 1-16. http://dx.doi.org/10.1155/2013/848043.

Gursoy, R.N., Benita, S., 2004. Self-emulsifying drug delivery systems (SEDDS) for improved oral delivery of lipophilic drugs. Biomed Pharmacother. 58(3), 173-182. http://dx.doi.org/10.1016/j.biopha.2004.02.001.

USP 41, 2018. The United States Pharmacopoeia, forty-first ed. Rockville: The Unites States Phamacopeial Convention.

Anand, O. et al., 2011. Dissolution Testing for Generic Drugs: An FDA Perspective. AAPS J. 13(3), 328-335. http://dx.doi.org/10.1208/s12248-011-9272-y.

Rossi, R.C. et al, 2007. Development and validation of dissolution test for ritonavir soft gelatin capsules based on in vivo data. Int J Pharm. 338(1-2), 119-124. http://dx.doi.org/10.1016/j.ijpharm.2007.01.036.

Dressman, J.B. et al, 1998. Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Immediate Release Dosage Forms. Pharm Res. 15(1), 11-22. http://dx.doi.org/10.1023/a:1011984216775.

Sheskey, P.J. et al., 2017. Handbook of pharmaceutical excipients, eighth ed. Pharmaceutical Press, London.

Asfaram, A. et al., 2017. Application of experimental design and derivative spectrophotometry methods in optimization and analysis of biosorption of binary mixtures of basic dyes from aqueous solutions. Ecotoxicol Environ Saf. 139, 219-227. Elsevier BV. http://dx.doi.org/10.1016/j.ecoenv.2017.01.043.

Darweesh, S.A. et al., 2018. Advancement and Validation of new Derivatives Spectrophotometric Method for Individual and Simultaneous Estimation of Diclofenac Sodium and Nicotinamide. Orient. J. Chem. 34(3), 1625-1632. http://dx.doi.org/10.13005/ojc/340357.

Mathew, C. et al., 2015. A green analytical method for the simultaneous analysis of cefixime trihydrate and ambroxol HCl based on ultraviolet derivative spectroscopy. Drug Development And Therapeutics. 6(2), 74-78. http://dx.doi.org/10.4103/2394-6555.162450.

Matias, R. et al., 2014. A UV spectrophotometric method for the determination of folic acid in pharmaceutical tablets and dissolution tests. Analytical Methods. 6(9), 3065-3071. http://dx.doi.org/10.1039/c3ay41874j.