VALIDACIÓN DE UN MÉTODO POR CROMATOGRAFÍA LÍQUIDA DE ALTA RESOLUCION (HPLC) PARA LOS ENSAYOS DE IDENTIFICACIÓN, POTENCIA, DISOLUCIÓN Y UNIFORMIDAD DE UNIDADES DE DOSIFICACIÓN DE MOXIFLOXACINA EN TABLETAS.

Abstract

Pharmaceutical companies have to demonstrate that the products they produce contain exactly the specified load of active chemical necessary to obtain a quality product. Validation is the scientifical process to do that and is an absolute requirement that every company must met, according to Good Manufacturing Practices (GMP) and the United States Pharmacopeial (USP), and must be properly documented, allowing assure that the methods used in the analysis of a product are reliable. Therefore, we want to validate the method of analysis for determining Moxifloxacin tablet which is manufactured in a national laboratory using the technique of high performance liquid chromatography (HPLC).