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Applying the analytical technique of energy dispersive X-ray fluorescence (EDXRF) the elemental composition of the film that coats gemfibrozil medicinal tablets has been determined. The respective EDXRF spectrum shows relatively intense characteristic K X-rays peaks of titanium about a hundred times more intense than the other X-ray peaks present in the spectrum. The quantitative analysis of this spectrum, based on the assumption that the material within the tablet in uniformly distributed, shows that the calculated amplitude of the K$_{\beta}$ X-rays of titanium is about 25\% larger than the recorded peak indicating that the titanium is distributed as a film. The literature gives reference to the application of titanium oxide for coating tablets. Based on this hypothesis the thickness of the TiO$_{2}$ oxide film is calculated to be 1.90 $\mu$m., Usando la técnica de fluorescencia de rayos-X dispersiva en energía (FRXDE) se ha obtenido la composición elemental de la película que recubre las tabletas medicinales de gemfibrozilo. Su espectro de FRXDE muestra picos de rayos-X característicos K de titanio, alrededor de cien veces más intensos que los otros rayos-X característicos presentes en el espectro. El análisis cuantitativo de este espectro, suponiendo una distribución uniforme del material que contiene la tableta, revela que la amplitud del pico K$_{\beta}$ de titanio es alrededor de 25\% más intenso que el registrado en el espectro. Lo cual da lugar a que se suponga que el titanio esté presente en la forma de una película muy delgada. La literatura hace referencia a la aplicación de TiO$_{2}$ para recubrir tabletas. Basado en esta hipótesis se ha calculado el grosor efectivo de esta película de TiO$_{2}$ de recubrimiento en recubre la tableta en 1.90 $\mu$m.

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.

Objetivo: Comparar efectos hipotrigliceridemiantes entre gemfibrozilo y aceite de Sacha Inchi en Rattus rattus var albinus. Materiales y Método: Se utilizaron 36 especímenes, los cuales fueron divididos al azar en 2 grupos experimentales (GE1 y GE2) y un grupo control (GC). Fueron sometidos a etapa de acondicionamiento por 2 semanas, luego alimentación rica en grasa por 2 semanas; posteriormente se administró aceite de Sacha Inchi y gemfibrozilo a GE1 y GE2, respectivamente. Se midieron los niveles de triglicéridos séricos en etapa basal, post-alimentación rica en grasa y tratamiento a una y dos semanas. Resultados: Disminución de niveles de triglicéridos séricos en GE1, GE2 y GC a dos semanas de tratamiento, de 45,57 %; 44,83% y 27,24% respectivamente. Diferencia de medias para GE1 y GE2 a una y dos semanas de tratamiento en relación a medias de valores postalimentación rica en grasa, fue muy altamente significativa; y diferencia entre grupos experimentales y GC a dos semanas de tratamiento fue significativa, con homogeneidad entre GE1 y GE2 (p=0,600). Conclusión: El aceite de Sacha Inchi demostró efectos hipotrigliceridemiantes, con eficacia similar al gemfibrozilo, en Rattus rattus var albinus, a una y dos semanas de tratamiento. Objective: To compare the triglyceride lowering effect of gemfibrozil against that of Sacha Inchi oil in Rattus rattus var albinus. Materials and Methods: Thirty-six animals were used. They were divided in two experimental groups (GE1 and GE2) and a control group (CG). The animals underwent a conditioning stage for two weeks, afterwards they were fed with fat-rich meals; and later, the animals from the two experimental groups received Sacha Inchi oil and gemfibrozil, respectively. Serum triglyceride levels were measured at the beginning of the trial, after receiving the fat-rich food and after one and two weeks receiving the test drugs. Results: Serum triglyceride levels had 45,57%, 44,83%, and 27,24% reductions in GE1, GE2 and CG groups, respectively, after two weeks receiving the test drugs. The mean difference of triglyceride values in GE1 and GE2 groups after one and two weeks receiving the test drugs was highly significant compared with values measured after receiving the fat-rich meals; and the difference between the experimental groups and the control group after two weeks using the test drugs was also significant, and the results obtained in the GE1 and GE2 groups were homogeneous (p= 0,600). Conclusion: Sacha Inchi oil showed a triglyceride lowering effect which was similar inefficacy to that of gemfibrozil in Rattus rattus var albinus, after one and two weeks using the test products.