Avaliação da estabilidade da associação de isoniazida e rifampicina

Abstract

Tuberculosis is a disease of older, known in the worid. The main treatment for this disease is achieved with the fixed-dose combination formulations, involving the main drugs. This study aims to determine the quality and conduct the first evaluation of stability of capsules of isoniazid and rifampicin formulations nationals with respect to physical, Chemical properties and dissolution after storage in accelerated conditions (40 ° C temperature and 75% RH) and under conditions of long duration (30 ° C temperature and 75% relative humidity). USP methods were used previously validated, based on visible spectrophotometry for the dissolution of rifampicin and high performance liquid chromatography for the content of rifampicin and isoniazid and disbandment. Four samples were submitted to six months of accelerated stability study and 12 months of stability study of long duration. The drugs were subjected to stressful conditions, performing hydrolysis at different pH values and temperatures. All formulations tested showed satisfactory for pharmacopoeial testing. In degradation studies, there were products resulting from the conditions imposed on drugs. But a more careful analysis, using methods more sensitive and specific instruments is needed to separate and quantify these degradation products. The formulations tested are nationals of good quality and monitoring the appearance of degradation products is needed throughout the stability study.