Development of Analytical Methods for the Determination of N-Bromosuccinimide in Different Active Pharmaceutical Ingredients by High-Performance Ion Chromatography with Suppressed Conductivity Detection

Product safety is important for medicines. For drugs on the market, it must be demonstrated that levels of toxic contaminants are below permitted limits. These impurities used as reagents or generated during synthesis. N-bromosuccinimide a brominating agent in synthesis some active pharmaceutical ingredients. The determination difficult due to its high reactivity. In this work, high-performance ion chromatographic method was developed N-bromosuccinimide. measurement can performed two ways, one involves assay resulting bromide and other via 3-carbamoyl propanoic acid produced from succinimide. Both ions were analyzed an anion exchange column by gradient elution with potassium hydroxide eluent detection suppressed conductivity detector. During development, results showed more selective than ion. Two different types ingredients (API), i.e., prasugrel favipiravir, chosen test sample preparation. both APIs, preparation vial consists liquid–liquid extraction alkaline reagent. Finally, chromatography validated at limit value level, harmonized guidelines. prasugrel, quantification limits accuracy level 7.2 ppm 96.4%, while favipiravir these 7.5 114.7%, respectively.