RP-HPLC法测定三七总皂苷注射液中9种皂苷的含量

Simultaneous determination of 9 compounds of saponins in PNS injections by RP-HPLC

目的建立同时测定三七总皂苷注射液中多种皂苷成分的RP-HPLC法.方法 Zorbax Eclipse XDB-C18色谱柱(250 mm×4.6 mm, 5 μm);乙腈-水梯度洗脱,乙腈:0～30 min,18%→19%;30～35 min,19%→35%;35～60 min,35%→55%.流速1.5 ml·min-1;检测波长203 nm;柱温为40 ℃.结果三七皂苷R1,人参皂苷Rg1、Re、Rf、Rb1、Rc、Rb2+Rb3和Rd的线性范围分别为0.24～4.75 μg(r=0.999 9),0.57～11.40 μg(r=1.000 0),0.50～9.90 μg(r=1.000 0),0.24～4.80 μg(r=1.000 0),0.54～10.65 μg(r=1.000 0),0.26～5.10 μg(r=1.000 0),0.25～4.90μg(r=1.000 0),0.32～6.30 μg(r=1.0000);平均回收率为99.3%～100.2%.结论 RP-HPLC法可同时测定三七总皂苷注射液中9种皂苷含量,有利于其质量控制.

Aim To establish a HPLC method for simultaneous determination of multiple components of saponins in PNS（ panax notoginseng saponins）injections. Methods Zorbax eclipse XDB-C18 column （250 mm×4.6 mm, 5μm） and gradient elution was used. Solvent A was acetonitrile and solvent B was water. The gradient program of solvent A was as follows： 0 -30 min, 18%→19% ; 30 -35 min, 19%→35% ;35 -60 min, 35%→55%. The flow rate was 1.5 ml·min^-1. Diode array detector was set at 203 nm and column temperature was 40℃. Results The linear ranges of notoginsensode R1 ,ginsensode Rg1 ,Re,Rf,Rb1 ,Rc,Rb2 ＋ Rb3 and Rd were 0.24-4.75μg（r =0.999 9） ,0.57 - 11.40μg（r = 1.0000） ,0.50 -9.90μg（r = 1.0000） ,0.24 -4.80 μg（ r = 1.0000） ,0.54 - 10.65μg（r = 1. 0000） ,0.26 - 5.10μg（ r = 1. 000 0） ,0.25 - 4.90 μg（ r = 1. 0000） and 0. 32 - 6.30 μg（ r = 1. 0000） respectively. The recoveries of 9 compounds of saponins were between 99.3% and 100.2%. Conclusion 9 components of saponins in PNS injections could be simultaneously determinated by using the RP-HPLC method,which will improve the quality control.