Determination of Atogepant Using RP-HPLC in Bulk and Table ts

Abstract

Context: Around one in seven individuals worldwide suffers from migraine, a highly prevalent and chronic neurological disease. In the prevention and treatment of migraines, 'gepants' are a class of receptor antagonist molecules that block calcitonin gene-related peptide (CGRP) receptors. Atogepant (ATO) is the first and only oral CGRP receptor antagonist (gepant) that was developed exclusively for the prevention and treatment of episodic migraines. Aim A stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method for the determination of ATO has been developed and validated in bulk and tablet dosage forms. Materials and Methods The chromatographic analysis was carried out on a Waters C18 Column with 250 mm × 4.6 mm and a particle size of 5 μm, using an isocratic mobile phase of Phosphate Buffer pH 3.6: Methanol: 0.5% Formic acid 60:38:2 v/v at a flow rate of 0.8 mL/min, and the eluents were monitored at an isosbestic point of 217 nm. Results The specificity, precision, accuracy, linearity, and robustness of the proposed method were all validated according to the ICH standards. Forced degradation studies confirmed the method's stability-indicating nature. ATO had retention time of 3.58 min. The current method was found to be accurate, precise, and sensitive. ATO linearity was achieved between 105 and 315 μg/mL, while LOD and LOQ were found to be 4.33 and 14.44 μg/mL, respectively. Conclusion As a result, the suggested RP-HPLC method for the quantification of ATO was reliable, reproducible, accurate, and sensitive.