Identification of the Impurities in Bopu Powder® and Sangrovit® by LC-MS Combined with a Screening Method

Bopu powder (R) and Sangrovit (R) were developed from Macleaya cordata and are widely used in agriculture and animal husbandry, but their impurities have been rarely reported in the literature. Impurity analysis is of great importance to the quality and safety of veterinary drugs. In this study, high-performance liquid chromatography/quadrupole time-of-flight mass spectrometry (HPLC-Q-TOF-MS) combined with a screening method was used to screen and characterize the impurities in Bopu powder (R) and Sangrovit (R). A total of 58 impurities were screened from Bopu powder (R) and Sangrovit (R) using the screening strategies, of which 39 were identified by their accurate m/z value, characteristic MS/MS data, and fragmentation pathways of references. This established method was used for impurity analysis for the first time and proved to be a useful and rapid tool to screen and identify the impurities of Bopu powder (R) and Sangrovit (R), especially for those at trace levels in a complex sample. In addition, this study marks the first comprehensive research into impurities in these two products and has great significance for the systematic detection of impurities in other plant-derived drugs.

Automated summary

This study successfully screened 58 impurities from Bopu powder and Sangrovit using HPLC-Q-TOF-MS technology, of which 39 were identified. The established method proved to be an effective and rapid tool for screening and identifying impurities in these two products, especially for trace impurities in complex samples.