Stability Indicating Analytical Method Development and Validation for the Estimation of Rimegepant in Bulk and Its Tablets Using Rp-HPLC

Abstract

Aim: Ramegepant is a novel molecule belongs to the class of calcitonin gene – related peptide (CGRP) receptor antagonist, which was developed for the prevention and treatment of migraine. Ramegepant was reported to act at the CGRP receptor with good oral bioavailability. The objective of this study was to develop a simple and fast stability indicating method for the determination of Ramegepant in bulk and tablets. Methodology: Ramegepant was eluted on a Waters C18 Column with 250 mm × 4.6 mm i.d and 5 μm Particle size with a mobile phase of Potassium dihydrogen orthophosphate buffer pH 7.0 : Methanol 30:70 v/v in isocratic mode at a flow rate of 0.8 ml/min. The analyte was quantified using a 272 nm PDA detector. Results: The chromatograms of Ramegepant obtained with this method showed a well resolved retention time at 3.29 min of its excipients and degradation products. The area of ​​the peak with respect to the concentration calibration curves, which were linear from 70 to 210 µg / ml, had a regression coefficient (r2) greater than 0.999. Accuracy and precision have been determined and perfectly matched to the ICH standards. Conclusion: The study showed that the proposed Rp-HPLC method was simple, fast, robust and reproducible, which can be used for the evaluation of the purity and stability of the drug without interference from excipients or decomposition products of active pharmaceutical ingredients.