Desarrollo y validación del método analítico para la determinación del marcador fitoquímico del extracto de aristeguietia glutinosa LAM, utilizado en el producto ¨Matico del Dr. Peña®¨ tabletas en el Laboratorio Neo Fármaco del Ecuador Neofarmaco Cia. Ltda.

Abstract

The present investigation aims developing and validating of the analytical method for purpose of phytochemical marker Aristeguietia glutinosa extract LAM, from MATICO DE DR. PEÑA Tablets. In the first stage, in the development analytical method, previous studies were contemplated to extract from Aristeguietia glutinosa LAM, flavonoids are established as metabolites of interest, using a liquid-liquid extraction technique to obtain them. Consisted of the use of organic solvents, to degrease the sample and a forced hydrolysis after the addition of an acidic medium and rise of temperature, to obtain the flavonoids in their glycine form. Afterwards, the sample was conditioned for its analysis both in chromatography of each fine and liquid chromatography of high efficiency; techniques with confirmatory tests were carried out against several known flavonoid standards, with Quercetin could be defined as the phytochemical marker. Then, after the study of biochemical and phytochemical characteristics of Quercetin and protocol for validation about analytical method were established and elaborated, based on reports from WHO, ICH, AEFI and USP; for pharmaceutical and natural products. After study from biochemical and phytochemical characteristics of Quercetin, the protocol for validation of analytical method was established and elaborated, based on reports from WHO, ICH, AEFI and USP; for pharmaceutical and natural products. Finally, methodology of analysis developed was obtained validation obtaining very good results and establishing as a phytochemical marker for Aristeguietia glutinosa LAM to Quercetin, fulfilling the purpose of the analytical method created, which was the routine assessment of both raw material MATICO FROM DR. PEÑA Extract, as the finished product MATICO DEL DR. PEÑA Tablets; inside the Laboratory NEO FÁRMACO DEL ECUADOR NEOFÁRMACO CIA. LTDA. In addition, it is important to raise awareness of support for this type of project, both the academic level and as level of private enterprise, so that the country can potentiate trade of quality natural products.