Evaluation Of The Chemical Stability Of Benznidazole--Cyclodextrin Complexes Through Forced Degradation Studies

Abstract

Forced degradation studies are essential for pharmaceutical development, manufacturing, and packaging to determine active substance stability. Benznidazole treats acute Chagas disease. This study uses forced degradation studies to examine the chemical behaviour of Benznidazole (Bzn) and its complexes under various stress conditions to understand better how cyclodextrins (CDs) improve solubility. It will also determine if the molecule's chemical stability and solubility improve. The current study validated the chromatographic method for linearity, selectivity, precision, and filter saturation. To evaluate linearity, the correlation coefficient of the analytical curve was calculated from Bzn solutions at concentrations of 5, 20, 50, 80, 120, and 150 µg/mL in a 50:50 (v/v) acetonitrile: water mixture found that R² value 0.998. Linearity, precision, and filter saturation indicate that this Bzn quantification method is adequate. There were solubility values of 0.261 mg/mL for Bzn, 0.809 mg/mL for Bzn- βCD complexes, and 0.819 mg/mL for Bzn- CD-CP. Bzn degraded in alkaline, oxidising, and light-treated solutions. Bzn did not degrade in acidic conditions, aqueous solution at 90ºC, or a solid state under the light. The Bzn molecule's nitro group causes photodegradation. After 30 minutes of exposure, HPLC-DAD detected peaks at 200 nm in the photostability test Bzn sample. The study concluded that the complexes with cyclodextrin (βCD and βCD-CP) that increased drug solubility did not protect Bzn due to similar chemical behaviour under stress conditions as the un-complexed molecule.