Simultaneous determination of seven active components of Fufang Danshen tablet by high performance liquid chromatography.

A high-performance liquid chromatography method was established for simultaneously determining seven major components, i.e. protocatechuic aldehyde, notoginsenoside R(1), ginsenoside Rg(1), salvianolic acid B, ginsenoside Rb(1), cryptotanshinone and tanshinone IIA in Fufang Danshen tablet, a commonly used traditional Chinese medicinal combined prescription mainly derived from the roots of Salvia miltiorrhiza and Panax notoginseng. These seven compounds, belonging to the chemical types of phenolic acids, diterpenoid quinones and saponins, were simultaneously separated on Zorbax C(18) column (250 x 4.6 mm, 5.0 microm) with the column temperature at 30 degrees C. The mobile phase was composed of (A) aqueous phosphoric acid (0.1%, v/v) and (B) acetonitrile using a gradient elution of 7-17% B at 0-10 min, 17-20% B at 10-12 min, 20-21% B at 12-16 min, 21% B at 16-32 min, 21-29% B at 32-40 min, 29-35% B at 40-55 min, 35-65% B at 55-65 min and 65-80% B at 65-80 min; the flow rate was 1.0 mL/min. Detection wavelengths were set at 203 nm for notoginsenoside R(1), ginsenoside Rg(1) and ginsenoside Rb(1), 281 nm for protocatechuic aldehyde, salvianolic acid B, and 270 nm for cryptotanshinone and tanshinone IIA. All calibration curves showed good linear regression (r(2) > 0.9992) within test ranges. The established method showed good precision and accuracy with overall intra-day and inter-day variations of 0.15-4.35 and 0.61-5.17% respectively, and overall recoveries of 94.8-102.1% for the seven compounds analyzed. The developed method has been successfully applied to simultaneous evaluation of the intrinsic quality of both Danshen and Sanqi in Fufang Danshen tablets from different pharmaceutical companies. Copyright 2006 John Wiley & Sons, Ltd.