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A reversed-phase high-performance liquid chromatographic method is developed in which low-wavelength ultraviolet detection is used to determine trace levels of residual dimethylsulfoxide (DMSO) in an antineoplastic agent, bisnafide (DMP 840 drug substance). The method is sensitive and free from interferences with a linearity for DMSO over a wide range of concentrations (0.219–3.288 μg/mL). The detection limit is approximately 0.051 μg/mL based on a signal-to-noise ratio of 3 and a 200-μL injection, and the limit of quantitation is approximately 0.219 μg/mL (relative standard deviation, 4.8%).

Quantitation of Residual Dimethylsulfoxide in a Drug Substance (Bisnafide) by Reversed-Phase High-Performance Liquid Chromatography