UPLC Fingerprint And Qualitative Analysis Study On Injectable Salvianolic Acid

Traditional Chinese Medicine Injection (TCMI) is a new dosage form originated from China. It has become an important part in the practice of Traditional Chinese Medicine (TCM). As a successful case, Salvianolic Acid for Injection (SAFI) is widely used clinically in the treatment of cardiovascular diseases (CVD) since 2012. It was demonstrated that phenolic acids possess different pharmacological effects including antioxidant, scavenging free radicals, inhibiting platelet function and improving microcirculation. Because the evaluation for the security of TMCI is complex system engineering, more basic research is needed to describe its security, efficiency and necessity. And the controllability of its quality should also be guaranteed. The aim of this study is to establish an UPLC method for fingerprint analysis of SAFI and qualitatively analyzing its constituents according to the relative molecule weight by LC-Q-TOF-MS and multistage MS information by LC-TOF-MS. Once the digital quantitative UPLC fingerprint was established, angel cosine and correlation coefficient were used to assess the quality levels of twenty-one batches of SAFI. The similarities of them were all over 0.960. Twenty-three compounds were identified as characteristic peaks of UPLC fingerprint. This method showed good characteristic and high specificity, and provided a new approach and technique support for the quality evaluation of listed TCMI.

Fig. 1: UPLC fingerprint of 21 batches of SAFI

Acknowledgement: This work was supported by National Key Special Project of Science and Technology for Innovation Drug of China (Grant No.

2013ZX09402202).