Validation of a chromatographic analytical method for quantification of benznidazole incorporated in nanostructured lipid formulations

Abstract

Benznidazole (BNZ) has been employed in the treatment of Chagas disease; however, its low water solubility is a drawback, which can be overcome by incorporating BZN within nanostructured systems. The aim of this work was to validate a chromatographic method for determination of BZN incorporated in nanoemulsions (NE) and nanostructured lipid carriers (NLC). The method was validated according to the International Conference on Harmonization guidelines. No interferences from the excipients of both systems on the BZN peak were observed. Linearity presented a correlation coefficient higher than 0.99 in the range of 5.0-30.0 μg mL-1. Relative standard deviation values for intra- and inter-days precision were lower than 2% and mean recovery ranged from 93.6 to 105.7%. BZN-loaded nanocarriers exhibited physico-chemical characteristics acceptable for parenteral administration and the encapsulation efficiency was almost 100% for both systems. The method shows a good potential to be employed in the determination of BZN in lipid nanostructures.