Multiple fingerprints and multi-comonent quantitative analysis of Danhong Injection / 中草药

ABSTRACT

Objective: To establish the multiple fingerprints of Danhong Injection (DI) using HPLC-UV-MS method and to simultaneously determine nine kinds of the medicinal components in DI. Methods: Separation was performed on Atiantis T3 analytical column (250 mm × 4.6 mm, 5 μm) with the mobile phase of 0.05% formic acid-50% acetonitrile by gradient elution, and negative-ion SIM mode was selected for mass spectrometric detection. Results: The multiple fingerprints reflected the chemical information of Salvia miltiorrhiza and safflower in DI. The similarity of the fingerprints was higher than 0.988 in all 11 batches of DI. 5-Hydroxymethyl furfural, sodium danshensu, protocatechuic aldehyde, coumaric acid, salvianolic acid D, rosmarinic acid, salvianolic acid B, salvianolic acid A, and kaempferol-3-O-rutinoside showed the good linearity in their respective ranges of concentration, r ≥ 0.999 0.The average recovery of low-, mid-, and high-dose medicinal components (n = 9) was (99.0 ± 1.4)%, (102.0 ± 1.7)%, (99.3 ± 1.6)%, (97.6 ± 1.6)%, (100.0 ± 1.8)%, (97.9 ± 1.6)%, (100.5 ± 4.4)%, (100.6 ± 2.0)%, and (106.0 ± 4.7)%, respectively. The relative standard deviation for the method reproducibility was lower than 1.45%. The total contents of nine medicinal components in the 11 batches of DI were 2.61-3.06 mg/mL. Conclusion: This method is simple, accurate, and with good reproducibility, and the multiple fingerprints combined with the quantitative analysis could reflect the quality of DI better, which could be used to control the quality of DI.