Zhang, Xinwen, et al. “Quantification of peptide components in cinobufacini injection and toad skin by Ultra‐High‐Performance Liquid Chromatography/Triple Quadrupole Mass Spectrometry.” Journal of Separation Science (2023): 2201048. https://doi.org/10.1002/jssc.202201048

Abstract

Cinobufacini injection is commonly used in clinical treatment of tumor and hepatitis B, but the quality uneven. Currently, the main focus of its quality assessment is on steroids and alkaloids. Based on previous study, we screened four peptides with high reproducibility, responsiveness and specificity. This research was first to develop an ultra-high-performance liquid chromatography/triple quadrupole mass spectrometry approach for evaluating the quality of cinobufacini preparations from the peptide perspective. In this study, we have identified 230 peptides in cinobufacini injection by Q-Exactive mass spectrometry, which contains species-specific peptides. Then, we used ultra-high-performance liquid chromatography/triple quadrupole mass spectrometry to establish a quantitative method for species-specific peptides and carried out method validation. The result revealed that four peptides were linear in a specific range, and had great reproducibility, accuracy and stability. Eventually, we evaluated the quality of 8 batches of cinobufacini injections and 26 batches of toad skins using the total content of target peptides as the criterion. The outcomes demonstrated that the quality of cinobufacini injection is generally stable and the toad skin from Shandong is of the best quality. In conclusion, the quantitative approach that focuses on peptides will offer innovative perspectives on assessing the quality of cinobufacini preparations.