High Performance Liquid Chromatography-Diode Array Detector Method for Benznidazole Quantitation in Lipid Based and Self Assembling Cyclodextrins Drug Delivery Systems

The challenge of the present work concerned in benznidazole assay in two drug delivery systems (DDS) which are different in the solubility character and sample complexity using HPLC-diode array detector (DAD) method. The lipid based DDS were mainly composed of medium-chain triglycerides and a mixture of surfactants, while the multicomponent inclusion complex systems involved cosolvents and different cyclodextrins. The method was validated according to the International Conference on Harmonization guidelines. The linearity of the standard curves was greater than 0.999 (r(2)) with the limits of detection of 0.05 mu g/mL and quantification of 0.18 mu g/mL. The method was specific, precise (RSD < 1.99%) and robust. The different drug interactions with systems did not alter the recovery which ranged from 93 to 106% for the distinct DDS. Statistical data analysis of different DDS demonstrated that selected parameters for HPLC-DAD method offered equivalent results and could be applied for stability studies and quality control of these drug delivery systems.