RIMEGEPANT REVIEW: ANALYTICAL PROFILE AND NEW DEVELOPMENTS

ABSTRACTIn order to measure Rimegepant (Nurtec ODT/Vydura) and evaluate its stability in bulk andtablet forms, this review summarizes validated RP-HPLC and LC-MS/MS analyticaltechniques. Using mobile phases of organic-aqueous mixtures, pH 7.0 phosphate buffers, oracidified systems with UV/PDA detection at 260–280 nm, chromatographic separations wereaccomplished on C18 stationary phases (150–250 mm × 4.6 mm, 5 μm) at flow rates of 0.8–1.0 mL/min. In order to maximize robustness and structurally characterize degradationproducts, Quality by Design (QbD) techniques and LC-MS/MS were integrated into both 25-minute gradient separations and fast isocratic runs (retention periods ~2.38–3.29 min).Theprocedures demonstrated great accuracy, precision (%RSD < 2.0%), and strong linearitythroughout concentration ranges from low trace levels (5–25 μg/mL, R^2=0.9999) to routineassay limits (70–210 μg/mL), all of which were fully consistent with ICH Q2(R1) validationguidelines. Three N-oxide impurities (m/z 566, 550, 548), two hydrolysis products (m/z 218,290), and important associated chemicals (RMM-4, RM-9, RM-E) were satisfactorilyresolved by forced degradation experiments, confirming stability-indicating capabilitiesthroughout acid, base, peroxide, heat, humidity, and photolytic stress.