改进HPLC法测定雷替曲塞原料药中的光学异构体

发布时间：2018-12-23 11:23

【摘要】：目的:改进高效液相色谱法测定雷替曲塞原料药中的光学异构体。方法:对色谱柱、流动相和进样量进行改进,改进后的色谱柱为CHIRALPAK AD-H,流动相为正己烷-无水乙醇-三氟乙酸(70∶30∶0.1,V/V/V),进样量为100μL,流速为1.0 mL/min,检测波长为226 nm,柱温为35℃。结果:光学异构体检测进样量线性范围为99.68~398.7 ng(r=0.999 9);定量限为4.945 ng,检测限为1.648 ng;精密度、稳定性、重复性试验的RSD1.0%;加样回收率为99.43%~100.14%(RSD=0.25%,n=9)。结论:改进后的方法简便、准确、灵敏度高、重复性好,可用于测定雷替曲塞原料药中的光学异构体。
[Abstract]:Objective: to improve the high performance liquid chromatography (HPLC) method for the determination of optical isomers in Reititrexe. Methods: the chromatographic column, mobile phase and injection volume were improved. The improved CHIRALPAK AD-H, mobile phase consisted of n-hexane-anhydrous ethanol-trifluoroacetic acid (70: 30: 0.1 V / V), and the injection amount was 100 渭 L. The flow rate was 1.0 mL/min, and the detection wavelength was 226 nm,. The column temperature was 35 鈩，

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