RP-HPLC法测定冠心宁冻干粉针中丹酚酸B含量

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

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（250mm×4．6mm，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286nm，流速1．0mL·min^-1，柱温30℃，进样量为10止。结果 丹酚酸B质量浓度在1．702-25．53mg·L^-1（r=0．9994，n=6）内与峰面积呈良好的线性关系，回归方程为A=1．05×10^4 ρ=5．21×10^2，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。

Objective To control the quality of Guanxinning injection powder. Methods A RP-HPLC assay was developed. The assay was performed on Hypersil ODS2 Cas column（250 mm × 4.6 mm, 5μm） with methanol-aeetonitrile-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 salvianolie acid B and peak area when salvianolie 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.