Quality control method for Guanxindanshen preparations

Objective To study the contents and determination method of cryptotanshinone,tanshinone I and tanshinone IIA in Guanxindanshen Capsules and Guanxindanshen Gutta Pills. Methods Ultrasonic extraction was used to extract the fat-soluble components of Guanxindanshen Capsules and Guanxindanshen Gutta Pills as samples and RP-HPLC assay was established to determine cryptotanshinone, tanshinone I and tanshinone IIA in these samples. The HPLC column was Diamonsil TM C 18(250 mm×4.6 mm,5 μm). The mobile phase was methanol-water(75∶25)with the flow rate of 0.8 mL/min and the detection wavelength was 270 nm. Results The calibration curves of cryptotanshinone,tanshinone I and tanshinone IIA were linear in the range of 1.456 to 10.190 mg/L,2.160 to 15.120 mg/L and 3.152 to 22.060 mg/L with the correlation coefficient beyond 0.999 1,0.999 2 and 0.999 6, respectively.The mean recoveries of the assay were 98.0% (RSD=1.30%,n=3) for cryptotanshinone,100.0% (RSD=0.96%,n=3) for tanshinone I and 99.3% (RSD=1.40%,n=3) for tanshinone IIA, respectively. Conclusion The method is rapid ,accurate and reliable, and can be used to control the quality of Guanxindanshen Capsules and Guanxindanshen Gutta Pills.