Quality control throughout the production process of Chinese herbal preparations using HPLC-DAD multiple chromatographic fingerprinting combined with HPLC/Q-TOF MS: a case study on Re Du Ning injections

Abstract

Recently, chromatographic fingerprinting has become one of the most powerful approaches for quality control of Chinese herbal preparations. In this study, “Re Du Ning injections (RDN)”, composed of Lonicerae japonicae Flos, Gardenia Fructus and Artemisiae annuae Herba, were investigated as a typical example to develop multiple chromatographic fingerprinting for quality control of the production process of Chinese herbal preparations. First, multiple HPLC fingerprints were developed, representing the different stages of samples in the production process of RDN. Moreover, the main constituents of the raw materials, intermediates and RDN were identified by HPLC/Q-TOF MS, and the characteristic compounds were selected on the basis of different types of compounds transformed in process routes. Then, the authentication and validation of these fingerprints were performed. Two sets of standards of relative peak areas for eight characteristic compounds in two raw materials, seven intermediates and one preparation in the production process of RDN were obtained based on the analysis of 10 batches of samples. One set was for the specified process, and the other one was for the whole process line of RDN. The quality control system was established by combining with these sets of standards. The results could provide some references for the Chinese Medicine Pharmaceutical Process control.