A comprehensive strategy for quality evaluation of Changan powder by fingerprinting combined with rapid qualitative and quantitative multi-ingredients profiling.

INTRODUCTION:Changan powder (CAP) is mainly used to treat various intestinal diseases. Few studies on CAP have been reported; therefore, it is necessary to clarify the material basis of CAP to lay the foundation for further elucidating its functional mechanism and support the rational use of drugs. OBJECTIVES:In the present study, we aimed to propose a methodology for the quality control of CAP based on qualitative and quantitative analysis of its components. METHODS:An ultra-performance liquid chromatography coupled with Fourier transform ion cyclotron resonance mass spectrometry (UPLC-FT-ICR-MS) method was developed to identify chemical components in CAP. In addition, fingerprints of 10 different batches of CAP were established, and quantitative analysis based on UPLC was performed to analyze the quality of CAP. RESULTS:A total of 58 compounds were preliminarily characterized. The similarity of 10 batches of CAP was greater than 0.995, and 23 common peaks were calibrated. Investigation of the quantitative analytical methodology showed that the four components had good linear relationships within their respective concentration ranges (r2 ≥ 0.9992), and the relative standard deviation (RSD) of precision and stability was less than 2%. The RSD of sample recovery ranged from 0.78% to 1.52%. CONCLUSION:The established method can quickly and effectively identify the chemical components of CAP and accurately quantify the known components in CAP. The established fingerprinting and content determination method is stable, reliable, and easy to operate and can be applied in quality control and in vivo research on CAP.