Quantitative research on multiple active components in Dandeng Tongnao Soft Capsules by UPLC-MS/MS-pattern recognition / 中草药

ABSTRACT

Objective: To establish a rapid MS method for the determination of nine principal active components (danshensu, caffeic acid, rosmarinic acid, salvianolic acid B, salvianolic acid A, tanshinone I, cryptotanshinone, tanshinone IIA, and ursolic acid) in Dandeng Tongnao Soft Capsules (DTSC), in order to make a comprehensive evaluation of the quality of drugs by pattern recognition technology. Methods: The UPLC-MS/MS method was used and the chromatographic conditions were as follows: The column was Acquity UPLC® BEH C18 (50 mm × 2.1 mm, 1.8 μm); The mobile phase was consisted of acetonitrile-water (containing 0.1% formic acid) at a flow rate of 0.2 mL/min with gradient elution; Mass spectrometer conditions: a triple quadrupole mass spectrometer equipped with electrospray ionization source (ESI) was used in positive and negative ion mode, and multiple reaction monitoring (MRM) was performed except ursolic acid in selected ion recording (SIR) for quantitative analysis of these compounds; The results of determination were calculated by the pattern recognition function of multivariate data processing software SIMCA 14.0 to evaluate the quality of DTSC. Results: Under the optimized conditions, danshensu, caffeic acid, rosmarinic acid, salvianolic acid B, salvianolic acid A, tanshinone I, cryptotanshinone, tanshinone IIA, and ursolic acid all showed good liners in the ranges of 100.0-1 000.0, 1.0-10.0, 8.0-80.0, 120.0-1 200.0, 15.0-150.0, 40.0-400.0, 10.0-100.0, 10.0-100.0, and 1.2-12.0 μg/mL, respectively (r ≥ 0.999 6). The recoveries were ranged from 98% to 101%, and RSDs were below 3%. The average contents in 10 batches of DTSC were (4.854 ± 0.314), (0.063 ± 0.005), (0.764 ± 0.070), (12.937 ± 0.648), (1.954 ± 0.178), (3.623 ± 0.221), (0.720 ± 0.062), (1.437 ± 0.116), and (0.073 ± 0.007) mg/g, respectively. The data were analyzed by SIMCA 14.0 software, and the results showed that the quality deviation of 10 batches of DTSC was below 2 SD (standard deviation, SD) range. Conclusion: The result shows that the UPLC-MS/MS method is simple, sensitive, and accurate for the rapid determination of main active components in the DTSC; It also shows that the quality of DTSC is stable in the different batches and displays an overall comprehensive evaluation of the drug quality using the multivariate data pattern recognition method, and provides a scientific basis and data processing method for the quality control of this drug.