Abstract
Currently, treatment of Chagas disease is restricted to the use of benznidazole and nifurtimox; however, nifurtimox was temporarily suspended in some countries. Based on the limitations in pharmacological treatments, it is essential to guarantee the quality of benznidazole. Therefore, this work aimed to identify the degradation products of benznidazole and to validate a stability indicating method. The stability test was performed through a forced degradation study, exposing benznidazole under a range of conditions. Benznidazole proved to be unstable under acidic and alkaline conditions, and three products were identified by liquid chromatography coupled to a hybrid quadrupole time-of-flight mass spectrometer (UPLC-QTOF-MS). Furthermore, a stability indicating method by high performance liquid chromatography with a diode array detector (HPLC-DAD) for benznidazole was developed and validated according to ICH (International Conference on Harmonisation) and ANVISA (Agencia Nacional de Vigilância Sanitaria) guidelines. The method was linear (180-420 µg mL-1 range), selective in the presence of degradation products, precise (relative standard deviation (RSD) 99.2%), robust, and free of matrix effects. The method was successfully able to quantify the benznidazole in pharmaceutical formulations.
Highlights
Chagas disease, which is caused by the parasite Trypanosoma cruzi, is considered a neglected disease and a public health problem.[1,2,3] According to the World Health Organization, about eight million people worldwide are affected by this pathology, and the majority of individuals live in Latin America.[1,4,5] The disease occurs in two phases: the acute and chronic phases
To achieve the best chromatographic profile of benznidazole and its degradation products, different conditions were tested to separate the analyte of interest from their DPs
Alkaline condition Benznidazole was submitted to degradation under the alkaline condition, as outlined in “Acidic and alkaline conditions” sub-sub-section, and the sample was analyzed by the HPLC-DAD method
Summary
Chagas disease, which is caused by the parasite Trypanosoma cruzi, is considered a neglected disease and a public health problem.[1,2,3] According to the World Health Organization, about eight million people worldwide are affected by this pathology, and the majority of individuals live in Latin America.[1,4,5] The disease occurs in two phases: the acute and chronic phases. The early phase of the pathology can be lethal in many cases, with intense parasite multiplication and cell invasion. The individual affected at this stage is asymptomatic or with symptoms common to any infection. The chronic phase of the disease is characterized by impairment of the digestive and/or cardiac system.[6,7,8,9]
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