Quality assessment of granule of Danshen extract by high performance liquid chromatography

AIM: To evaluate the quality of the granule of Danshen extract (GDE) by simultaneously determining the phenolic and tanshinone components with high performance liquid chromatography. METHODS: A Waters SymmetryShield RP18 (2.1 mm x 100 mm, 3.5 μm) with a Waters symmetryShield RP18 guard column (2.1 mm x 10 mm, 5 μm) was used for the analysis. The separation was performed with a gradient mobile phase of A (0.1% formic acid in water) and B (0.1% formic acid in acetonitrile) at a flow rate of 0.2 min·mL-1. The column was thermostated at 30 °C and the detection wavelength was set at 280 nm. Peaks were identified by comparing the accurate molecular weight with Waters Q-TOF premier system. RESULTS: HPLC profiles of GDE showed different patterns. Eight major components were quantitative analysis, and contents of the major components in GDE varied between manufacturers. The total amounts of major components in the granules were less than or equivalent to the amount in the decoction of Danshen, and the daily amounts of the major components in the commercial Danshen granules were only about 1/65-1/2.8 of those in the decoction of Danshen. CONCLUSIONS: The contents of major components in GDE varied between manufacturers and were lower than those in the decoction of Danshen. The actual values of concentrative factor of commercial GDE do not meet their labels. It was demonstrated that extract solvents, temperature and heating time are the factors to influence the composition of GDE. In conclusion, standardized criteria for the quality control of GDE should be established and the manufacturing process, the criteria for raw material selection should be assessed and improved.