Separation and Characterization of the Components and Impurities in Policresulen Solution using LC-Q-TOF MS

Background: As an external medicine, policresulen solution didn't get much attention throughout the world. From the paper which had been published yet, there has been no report concerning other unknown impurities in the policresulen solution. Four known components had been identified as well as quantified, however, as long as people’s concern for drug safety increased rapidly, there still remain impurities to be studied. Objective: This paper focuses on the separation and characterization of the impurities in the policresulen solution, which is critical for controlling the production of this drug. Methods: The components and impurities in the policresulen solution were separated and characterized using HPLC coupled with to Q-TOF mass spectrometry. An ACE EXCEL 5 C18-PFP column (4.6 mm×250 mm, 5 μm) was used, and the mobile phases were 0.01 M ammonium acetate solution and methanol. Results: 21 previously unknown impurities were separated and characterized in a policresulen solution, and the structures were proposed based on the MS/MS fragmentation data. Conclusion: Based on the characterization of impurities, this study showed that there remain lots of oligomers in the policresulen solution, apart from four known components. This study could be used for further analytical analysis of the policresulen solution, which could improve the quality control of the policresulen solution and other preparations recommended in pharmacopoeias.