Simultaneous determination of seven index components in Refined Coronary Tablet by HPLC / 中草药

ABSTRACT

Objective: To develop an HPLC method for the simultaneous determination of tanshinone IIA, paeoniflorin, salvianolic acid B, ferulic acid, safflor yellow A, ligustilide, and danshensu in Refined Coronary Tablets. Methods: The chromatographic separation was achieved on a Zorbax Eclipse XDB-C18 column (250 mm × 4.6 mm, 5.0 μm) with methanol-acetonitrile (25∶75, A)-0.1% formic acid (B) as mobile phases at the flow rate of 1.0 mL/min for gradient elution 0-10.0 min, 95% B; 10.0-16.0 min, 95%-85% B; 16.0-18.0 min, 85% B; 18.0-22.0 min, 85%-75% B; 22.0-26.0 min, 75%-65% B; 26.0-40.0 min, 65%-15% B; Detection with variable wavelength 0-19.0 min was 270 nm, 19.0-22.0 min was 230 nm, 22.0-27.0 min was 320 nm, 27.0-40.0 min was 402 nm, and the column temperature was 30 ℃. Its linear relationship, precision, repeatability, stability, and recoveries were investigated. Results: The results showed that the seven active components were well separated and showed good linearity, tanshinone IIA 0.4-8.0 mg/L (r = 0.999 5), paeoniflorin 1.2-24.0 mg/L (r = 0.999 1), salvianolic acid B 3.2-64.0 mg/L (r = 0.999 3), ferulic acid 0.08-1.60 mg/L (r = 0.999 5), safflor yellow A 1.2-24.0 mg/L (r = 0.999 3), ligustilide 0.24-4.80 mg/L (r = 0.999 7), and danshensu 0.32-6.40 mg/L (r = 0.999 7). The precision was good, and RSD was less than 2.0%. The repeatability was good, and RSD was less than 2.0%. The stability was good in 12 h. The average recoveries were between 98.05%-101.27%, and RSD was less than 2.0%. The contents of target components in Refined Coronary Tablets, tanshinone was 0.704-0.797 mg/g, paeoniflorin was 3.124-3.411 mg/g, salvianolic acid B was 7.129-7.611 mg/g, ferulic acid was 0.180-0.198 mg/g, safflor yellow A was 2.718-2.966 mg/g, ligustilide was 0.590-0.683 mg/g, and danshensu was 0.811-0.899 mg/g. Conclusion: The method is accurate, sensitive, credible, and repeatable. It can be applied to the quality control of Refined Coronary Tablets.