Qualitative and Quantitative Analysis of the Major Ingredients of a Herbal Preparation, Ciwujia Injection by Combination of HPLC-Q-TOF-MS, HPLC-TQ-MS/MS and UPLC-PDA

Background: Ciwujia injection, prepared from water extraction of Acanthopanax senticosus, is widely used for the treatment of cardiovascular diseases in the clinic in China. The ingredients of the preparation are still not efficiently clear and its quality control method requires further improvement. Objective: In this paper, the qualitative and quantitative methods for quality control of Ciwujia injection were originally developed by a combination of HPLC-Q-TOF-MS, HPLC-TQ-MS/MS and UPLCPDA. Methods: With HPLC-Q-TOF-MS and HPLC-TQ-MS/MS, compounds were identified firstly by comparison of their MS spectra and retention times with those of standards or recorded information in the literature. Further, a new UPLC-PDA method was originally established to simultaneously determine the multiple ingredients in the preparations. Results: For qualitative analysis, 22 compounds were identified by the presented method. For quantitative analysis, the validated method exhibited good linearity (R2 > 0.998), repeatability (RSD < 1.50%), intra- and inter-day precisions (RSD < 8.33%) and recoveries (95.93-108.58%) for the simultaneous determination of the active ingredients, including protocatechuic acid-3-glucoside, l-phenylalanine, protocatechuic acid, neochlorogenic acid, chlorogenic acid, gentiopicroside, eleutheroside B, and cryptochlorogenic acid, and was successfully utilized to analyze the eight compounds in 4 batches of Ciwujia injection. Conclusion: The presented method is simple and rapid for quality control of Ciwujia injection, and could provide a useful reference for the quality control and routine analysis of others Ciwujia preparations.