Volume 2 - Issue 3, May - June 2026

Reported literature on Zavegepant mainly emphasizes LC-MS/MS bio-analytical methods for pharmacokinetic studies, with limited availability of simple stability-indicating RP-HPLC methods for routine quality control.A stability-indicating analytical approach is necessary for the production, storage, and shipment of Zavegepant, a medicine used to treat acute migraines, an antagonist to the calcitonin generelated peptide (CGRP) receptor. Methodology: Chromatographic separation was achieved using a YMC Accura Triart Bio C4 column (250 × 4.6 mm, 5 µm) with a mobile phase consisting of 10 mM ammonium bicarbonate in water and acetonitrile (65:35 v/v) at a flow rate of 0.7 mL/min. Detection was performed at 220 nm with a column temperature maintained at 35°C. The method was validated for system suitability, specificity, precision, linearity, accuracy, LOD, LOQ, robustness, ruggedness, assay, and forced degradation studies. Results and Discussion: Zavegepant showed a sharp peak at a retention time of 5.916 minutes. The system suitability study demonstrated excellent precision with %RSD values of 0.083% for peak area and 0.093% for retention time. The method was linear over the concentration range of 0.2–0.75 µg/mL. Accuracy studies showed mean recoveries of 100.83%, 100.46%, and 101.16% at 50%, 100%, and 150% levels, respectively. The LOD and LOQ showed signal-to-noise ratios of 7.73 and 15.29. The assay of Zavzpret showed 99.50% drug content. Forced degradation studies revealed significant acid degradation, moderate oxidative degradation, and stability under basic and thermal conditions. Conclusion: The developed RP-HPLC method was found to be sensitive, accurate, robust, reproducible, and stabilityindicating, making it suitable for routine quality control and stability studies of Zavegepant.

K.Vyshnavi, B.Malathi, C.Hari Kumar, M.Pradeep Kumar, B.Pavani,"Design and Validation of a Robust Stability-Indicating RP-HPLC Method for Zavegepant in Zavzpret Nasal Spray" International Journal of Advanced Multidisciplinary Research and Educational Development, V2(3): Page(205-219) May-June 2026. ISSN: 3107-6513. www.ijamred.com. Published by Scientific and Academic Research Publishing.