Qualitative and Quantitative Analysis of Danshen-chuanxiongqin Injection by Using UHPLC-Q-Orbitrap HRMS / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish an analytical method of ultra performance liquid chromatography-quadrupole/orbitrap high resolution mass spectrometry (UHPLC-Q-Orbitrap HRMS) for identification and quantitation of the multi-constituents of Danshen-chuanxiongqin injection. METHODS: The method of UHPLC-HRMS was developed to identify the complex chemical composition and full ms scan mode was used to determine the main active ingredients precisely, then the means of principal component analysis (PCA) was used to comprehensively assess the quality of Danshen-chuanxiongqin injection. RESULTS: A total of 23 chemical constituents were identified in Danshen-chuanxiongqin injection, 14 of which were unambiguously identified by comparing with chemical standards, and seven major compounds, ligustrazine, danshensu, salvianolic acid A, succinic acid, rosmarinic acid, protocatechuic aldehyde, caffeic acid, in Danshen-chuanxiongqin Injection were determined accurately. The analysis by multivariate data processing software SIMCA 14.0 indicated that the quality of most batches of samples were stable except ligustrazine, danshensu, and salvianolic acid A which were a bit unstable in some individual batches, and it was essential to monitor the content of salvianolic acid A to control the drug quality. CONCLUSION: The established HPLC-TOF-MS/MS method has the properties of rapid identification, high specificity, simpliness, and feasibility, which can be used as a better means for the qualitative and quantitative analysis of danshen-chuanxiongqin injection. Moreover, it lays the ground for quality control of the drug and provides data reference for the rational use in clinic.