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DEVELOPMENT OF ANALYTICAL METHOD FOR QUANTIFICATION OF ANTINEOPLASTIC IN DRUG DELIVERY SYSTEMS In recent years, there has been a growing number of researches involving nanotechnology to obtain controlled release drugs, these systems can: protect the drug against biological and physico-chemical incompatibilities; controlling the bioavailability of the drug. Although with all these advantages there are no in vitro methods really capable of accurately predicting drugs release by such systems, therefore, the development of in vitro release methods to determine the release kinetics of such systems is very important. The objective of the present work was to develop and validate capillary electrophoresis (CE) and HPLC methods to determine the encapsulation efficiency of the imatinib drug in previously elaborated and characterized nanoparticles, as well as to study its release in vitro by CE method. The nanoparticles were synthesized using the nanoprecipitation method and characterized by size, zeta potential, morphology and encapsulation efficiency. Capillary electrophoresis is a very promising alternative to HPLC because of its low cost, less runtime and less polluting environment. The CE and HPLC methodswere developed and validated according ICH, American Pharmacopoeia and ANVISA guidelines.Developed nanospheres had an average diameter close to 150nm, with polydispersity index less than 0.1 and approximately 90% encapsulation efficiency. Both methods were linear with determination coefficients higher than 0.99, the methods were precise (%RSD < 2), accurate (101.0±4,2% and 98.0±2,5% for HPLC and CE, respectively) and selective. Capillary electrophoresis method allowed to develop a drug release study independent of dialysis membranes.

Desenvolvimento de método analítico para quantificação de antineoplásico em sistemas de liberação controlada de fármacos