SUZETRIGINE: STUDY, ESTIMATION AND DEVELOPMENT OF ANALYTICAL METHODS BY GAS CHROMATOGRAPHY — A REVIEW

GC is well suited to the intact molecule suzetrigine has a molecular weight of 473.4, two amide groups one a primary carboxamide and four stereocentres, so it has low volatility and is prone to thermal degradation and on-column adsorption. GC nevertheless has firm roles in suzetrigine quality control, residual solvents in the API, volatile process impurities and reagents, and potentially mutagenic low-molecular-weight impurities. A derivatisation-based GC-MS strategy for the parent drug, intended for forensic or toxicological screening, is outlined along with its ICH Q2(R2) validation plan.