A rapid quality control method for seven marker components in Shuangsen Tongmai Dripping Pill by HPLC-MS

AIM: To improve the safety,efficacy,stability,and controllability of Shuangshen Tongmai Dripping Pill(Radix et Rhizoma Ginseng,Radix et Rhizoma Salviae miltiorrhizae,Rhizoma Chuanxiong).METHODS: In this study,RP-HPLC and MALDI-TOF-MS were used to establish a method for rapid quality control of Shuangsen Tongmai Dripping Pill,with the amount of tanshinone ⅡA as a marker.C18-ODS column(150 mm × 4.6 mm I.D.5 μm,shimadzu) was adopted with the mobile phase of a mixture of acetonitrile and 0.5 acetic acid in gradient elution mode,at a flow rate of 1.0 mL/min and column temperature at 25 ℃.RESULTS: With the detection wavelength at 203 nm,ginsenoside Rg1,Rb1 and Re,tanshinone ⅡA could be simultaneously assayed.With the detection wavelength at 270 nm,tanshone ⅡA,salvianolic acid B,ferulic acid,and chuanxiongzine could be simultaneously assayed.Regression equations revealed good linear relationship between the peak areas of the constituents and their concentration ranges.MALDI-TOF-MS analysis showed the identical molecular weight of tanshinone ⅡA among samples.CONCLUSION: The method is rapid and accurate with good resolution,stability and reproducibility and could be used to monitor seven marker components in Shuangsen Tongmai Dripping Pill quantitatively.The proposed method could also be used for the quality monitoring of other products containing Radix et Rhizoma Ginsong and Radix et Rhizoma Salviae Miltiorrhizae,or Radix et Rhizoma Salviae Miltiorrhizae and Rhizoma Chuanxiong,and for the in vivo pharmacodynamical and pharmacokenetical studies.