RP-HPLC法测定冠心宁冻干粉针中丹酚酸B含量

目的测定冠心宁冻干粉针中丹酚酸B的含量,控制冠心宁冻干粉针的质量。方法采用RPHPLC法。色谱柱为Hypersil ODS2 C18柱(250 mm×4.6 mm,5μm),流动相为甲醇乙腈体积分数为1.7%的甲酸水溶液(体积比为15∶12∶73),检测波长286 nm,流速1.0 mL.min-1,柱温30℃,进样量为10μL。结果丹酚酸B质量浓度在1.702~25.53 mg.L-1(r=0.999 4,n=6)内与峰面积呈良好的线性关系,回归方程为A=1.05×104ρ-5.21×102,平均回收率为99.8%(RSD=2.9%,n=9)。共测定了3批冻干粉针样品,含量质量分数分别为10.7%、9.0%、7.55%,RSD值分别为0.1%、0.1%、0.3%。结论测定方法灵敏、准确、重复性好,可作为评价冠心宁冻干粉针质量的方法。

Determination of salvianolic acid B in Guanxinning injection powder by RP-HPLC

Objective To control the quality of Guanxinning injection powder.Methods A RP-HPLC assay was developed.The assay was performed on Hypersil ODS2 C_(18) column(250 mm×4.6 mm,5 μm) with methanol-acetonitrile-1.7% formic acid(V∶V∶V=15∶12∶73) as mobile phase.The detection wavelength was set at 286 nm,when the flow was 1.0 mL·min~(-1).And the column temperature was 30 ℃.The injection volume was 10 μL.Results Good linear correlation was obtained between the content(w) of salvianolic acid B and peak area when salvianolic acid B was in the range of 1.702-25.53 mg·L~(-1)(r=(0.999 4),n=6) and the regression equation was A=1.05×10~4 ρ-5.21×10~2.The average recoveries were 99.8%(RSD=2.9%,n=9).Three batches of samples were analyzed,the contents(w) were 10.7%,9.0% and 7.55%,respectively,while RSDs were 0.1%,0.1% and 0.3%.Conclusions The method is reliable,accurate and reproducible,it can be used for the quality control of Guanxinning injection powder.