反相高效液相色谱法测定福多司坦的含量

RP-HPLC determination of fudosteine

目的:采用反相高效液相色谱法建立福多司坦原料药的含量测定方法。方法:采用Shimadzu C_(18)色谱柱(150mm×6.0mm,5μm),以乙腈-水(含0.02mol·L^(-1)戊烷磺酸钠,用磷酸调节pH 至2.1)(4∶96)为流动相,流速为1mL·min^(-1),柱温为室温,检测波长为210nm。结果:空白及中间体对样品测定不产生干扰;福多司坦在10.1～151.5μg·mL^(-1)浓度范围内与峰面积呈良好线性关系;平均回收率为99.86%(n=9);RSD 为0.48%(n=6)。结论:本法可用于福多司坦原料药的含量测定。

Objective:To establish a method for determination of fudosteine.Methods:A columnof Shimadzu C_(18) column (150mm×6.0mm,5μm) at room temperature,a mobile phase consisting ofacetonitrile:0.02mol·L^(-1) sodium pentane-sulfonate solution (pH 2)=4∶96 with a flow rate of 1mL·mmin^(-1),and a UV detector at 210nm were adopted.Results:A linear range of 10.1～151.5μg·mL^(-1),amean recovery 99.86% (n=6) with a RSD of 0.48% were obtained.Conclusion:A simple and accu-rate method is established for determination of fudosteine in its bulk pharmaceutical chemical.