反相高效液相色谱法测定雷洛昔芬自微乳中的药物含量

RP-HPLC determination of raloxifene in raloxifene self-microemulsion

目的建立雷洛昔芬自微乳中雷洛昔芬的含量测定方法。方法采用反相高效液相色谱法,以乙腈-0.01 mol·L^-1十二烷基硫酸钠溶液（体积比55：45）为流动相,紫外检测波长289 nm,流速1.0 m L·min^-1。结果雷洛昔芬在1.0-40.0μg·m L^-1与峰面积线性关系良好,回归方程为A=6.922×104C＋1.716×104,r=0.999 9,平均回收率为101.3%,RSD为0.83%。结论该法简便、快速、重复性好,可用于雷洛昔芬自微乳中雷洛昔芬的质量控制。

Objective To establish the determination method of raloxifene in raloxifene self-microemulsion. MethodsRP-HPLC was used with the mobile phase consisting of acetonitrile-0.01 mol·L^- 1 twelve sodium dodecyl sulfate solution（volume ratio 55 ： 45）. The UV detection wavelength was 289 nm. The flow rate was 1.0 m L·min^- 1. Results Raloxifene was linear at 1.0- 40.0 μg·m L^- 1, A = 6.922×104C ＋ 1.716×104, r = 0.999 9, and the average recovery of raloxifen was 101.3%, with RSD of 0.83%. Conclusion The method is rapid, simple, and highly reproducible, which can be used for the quality control of raloxifene in raloxifene self-microemulsion.