Determination of atogepant using RP-HPLC in bulk and tablets: A stability-indicating analytical method

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 x 4.6 mm and a particle size of 5 mu m, 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 mu g/mL, while LOD and LOQ were found to be 4.33 and 14.44 mu g/mL, respectively. Conclusion:As a result, the suggested RP-HPLC method for the quantification of ATO was reliable, reproducible, accurate, and sensitive.