Validation of analytical method by UV spectrophotometric quantification of gemfibrozil incorporated in the microemulsions
Barra lateral del artículo
Contenido principal del artículo
Resumen
The present study aims to validate an analytical method by UV spectrophotometric for the quantification of gemfibrozil incorporated into microemulsions. Experimental development by constructing a ternary phase diagram for the identification of microemulsions. The characterization of the microemulsions was carried out by the polarized light microscopy technique. The analytical method was validated according to the parameters described by the United State Pharmacopeia (USP) 39 NF34 and International Conference on Harmonization (ICH) (2005), which evaluated linearity, robustness, intra and inter day accuracy, specificity accuracy, limits of detection and quantification. The developed method demonstrated linearity with a coefficient of determination (R2) of 0.9898, in addition to precision, accuracy and robustness for each of the tests with values that presented a coefficient of variation of less than 5 %. The results obtained were favorable, since they comply with the parameters stipulated by USP 39-NF34 (2016) and ICH (2005), indicating that the method is effective for the intended purpose.
Descargas
Detalles del artículo
- Los autores se comprometen a respetar la información académica de otros autores, y a ceder los derechos de autor a la Revista infoANALÍTICA, para que el artículo pueda ser editado, publicado y distribuido.
- El contenido de los artículos científicos y de las publicaciones que aparecen en la revista es responsabilidad exclusiva de sus autores. La distribución de los artículos publicados en la Revista infoANALÍTICA se realiza bajo una licencia Creative Commons Reconocimiento-CompartirIgual 4.0 Internacional License.
Citas
Addas Rahdar; Taboada Pablo; Reza Hajinezhad Mohammad; Barani Mahmood; Beyzaei Hamid (2018). Effect of tocopherol on the properties of Pluronic F127 microemulsions: Physico-chemical characterization and in vivo toxicity. v 277, p. 624-630.
Benítez, N., Cordoví, J. M., Fernández, M., Zamora, R., De La Paz, N., & Cabrera, P. (2014). Validación de métodos analíticos aplicables al control de calidad y estudio de estabilidad de las gotas nasales de efedrina. Ars Pharmaceutica, 55(3), 11–18.
Cáceres, D. H., Zapata, J. D., Granada, S. D., Cano, L. E., & Naranjo, T. W. (2016). Estandarización y validación en Colombia de una metodología basada en HPLC para la determinación de la concentración sérica de posaconazol. Revista Iberoamericana de Micologia, 33(4), 230–236.
Callender, S. P., Mathews, J. A., Kobernyk, K., & Wettig, S. D. (2017). Microemulsion utility in pharmaceuticals: Implications for multi-drug delivery. International Journal of Pharmaceutics, 526(1–2), 425–442.
Cáñez-Carrasco, M. G., & García-Alegría, A. M. (2015). Validación de un método analítico para la determinación de fósforo por espectrofotometría ultravioleta-visible. Biotecnia, 17(1), 32.
Cubas, J. M., Pimentel, R. G. C., Enrique, I., Merlín, M., & Martínez, E. S. M. (2018). La espectroscopia UV-Vis en la evaluación de la viabilidad de células de cáncer de mama. Lat. Am. J. Phys. Educ. Vol, 12(2), 2307-1.
Davoodi, P., Lee, L. Y., Xu, Q., Sunil, V., Sun, Y., Soh, S., & Wang, C.-H. (2018). Drug delivery systems for programmed and on-demand release. Advanced Drug Delivery Reviews.
El Maghraby, G. M., Arafa, M. F., & Essa, E. A. (2018). Phase transition microemulsions as drug delivery systems. Applications of Nanocomposite Materials in Drug Delivery. Elsevier Inc.
Ferreira, G. F. D., Souza, D. R. Q., Lima, R., Lobato, A. K. C. L., Silva, A. C. M., & Santos, L. C. L. (2018). Novel glycerin-based microemulsion formulation for enhanced oil recovery. Journal of Petroleum Science and Engineering, 674–681.
Froelich, A., Osmałek, T., Snela, A., Kunstman, P., Jadach, B., Olejniczak, M., Roszak, G., Białas, W. (2017) Novel microemulsion-based gels for topical delivery of indomethacin: Formulation, physicochemical properties and in vitro drug release studies, Journal of Colloid and Interface Science
Gaete, F. (2014). Validación de la metodología analítica de Paracetamol y aplicación a un estudio de bioexención. Santiago.
Gvaramia, M., Mangiapia, G., Falus, P., Ohl, M., Holderer, O., & Frielinghaus, H. (2018). Capillary condensation and gelling of microemulsions with clay additives. Journal of Colloid and Interface Science, 525, 161–165.
Huo, R., Yang, X. L., Liu, Y. Q., & Xu, Y. H. (2017). Visible-light photocatalytic degradation of glyphosate over BiVO4 prepared by different co-precipitation methods. Materials Research Bulletin, 88, 56–61.
ICH Validation of analytical procedures: text and methodology Q2(R1) (2005). International Conference on Harmonization, 1-13.
Lozano, X., Zhang, S., Ma, H., Dong, P., Ma, X., Xu, M., Zhang, J. (2018). In situ monitoring of the structural change of microemulsions in simulated gastrointestinal conditions by SAXS and FRET. Acta Pharmaceutica Sinica B, 8(4), 655–665.
Silva, C. F.; Severino, P.; Martins, F.; Chaud, M.V.; Santana, M.H.A. (2008). The intestinal permeation of didanosine from granules containing microspheres using the everted gut sac model. 1-6
Tornio, A., Neuvonen, P. J., Niemi, M., & Backman, J. T. (2017). Role of gemfibrozil as an inhibitor of CYP2C8 and membrane transporters. Expert Opinion on Drug Metabolism and Toxicology, 13(1), 83–95.
United States Pharmacopea USP39 NF34 (2016)
Valcárcel, J. P., González, H., & Valcárcel, D. H. (2008). Espectroscopia. fundamento de la resonancia magnética nuclear. Entornos, 1(21), 89-94.