Abstract:

Abstract:Objective To establish a new method to determine the contents of  matrine and oxymatrine in Qingre Tonglin Tablet by high performance liquid chromatography(HPLC),in order to optimize the quality evaluation and control of Qingre Tonglin Tablet. Methods HPLC method was adopted.Matrine and oxymatrine standards were the control substances and Qingre Tonglin Tablets were the experiment samples.Using Agilent 1200 high performance liquid chromatograph,the determination was performed on Genimi-C18 (5  μm,4.6 mm×250 mm) column with mobile phase consisting of phosphate buffer solution (PH3.0) - methanol (93∶7) at the flow rate of  0.8 mL/min.The column temperature was 35℃.The detection wavelength was 220 nm and the injection volume was 10  μL.For the methodological study,thelinearity,specificity,stability,precision and repeatability and accuracy of the HPLC method were tested. Results The regression equation of matrine was Y=1102.1X+15.423,showing good linearity (r=0.999 9 ) in the range of 0.311　8-4.677　0 μg.the average recovery rate was 97.1% (RSD = 0.24%,n=6). The regression equation of oxymatrine was Y=1106.6X+5.040 2,showing good linearity (r=0.999　6) in the range of 0.029　8-0.446 4 μg; the average recovery rate was 98.4% (RSD=1.52%,n=6). In the tests of stability,precision and repeatability,the RSD of matrine and oxymatrine were respectively 1.21%,1.47%; 0.13%,2.76%; 0.48% (RSD of the sum of matrine and oxymatrine). Conclusion HPLC method issimple,sensitive, reliable,specific and has satisfactory separation results,and it is competent for the quality control of QingreTonglin Tablet.

Key words: high performance liquid chromatography, Qingre Tonglin Tablet, matrine, oxymatrine