Desarrollo y validación de un método analítico por UPLC para la determinación de ampicilina en una matriz biológica obtenida en ensayos de permeabilidad in vitro.

Abstract

Due to in Colombia has not been reported models of permeability in vitro as a tool for predicting the oral bioavailability of new or existing active substances, nor has driven the development of analytical methodologies to quantify them in complex biological matrices from these models. This reflects a problematic; not having these methodologies hinders the knowledge of pharmacokinetics and limits the applicability of pharmaceutical strategies to improve bioavailability of substances that have absorption problems such as the beta-lactam antibiotics. In this project, a quick and simple analytical method was developed using Efficiency Ultra Performance Liquid Chromatography (UPLC) to quantify the fraction permeated ampicillin in Caco-2 intestinal epithelial cells , in order to predict in vivo absorption. Additionally, the analytical methodology was validated following the guidelines established by the United States Pharmacopeia in the Validation of compendial methods and by the Food and Drug Administration in the Guide for Validation of Bioanalytical Methods, finding that it meets parameters of performance such as selectivity, precision, accuracy and linearity.