Determination of chlordiazepoxide, its hydrochloride and related impurities in pharmaceutical formulations by reversed-phase high-performance liquid chromatography.

A quantitative high-performance liquid chromatographic method using an octadecylsilane column and a methanol-water mobile phase was employed for the determination of chlordiazepoxide, chlordiazepoxide X HCl and related impurities in capsule and tablet preparations. Each component is well separated and directly detected by 254 nm absorption. For chlordiazepoxide and chlordiazepoxide X HCl the coefficient of variation for replicated injections was below 1%. Recovery of authentic samples ranged from 98.4 to 101.6% for both capsule and tablet formulations.