高效液相色谱法测定注射用奥拉西坦的含量

摘要

目的 建立测定注射用奥拉西坦含量的高效液相色谱法.方法 色谱柱为Ultimate C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(5∶95),检测波长为214 nm,流速为0.8mL/min.结果 奥拉西坦含量测定线性范围为0.0404～0.323 2 g/L(r=0.999 8),平均回收率为99.6%,RSD为1.1%(n=6).结论 该含量测定方法简便、准确、重复性好,可有效控制注射用奥拉西坦的质量.%To eslablish a method for the determination of Oxiracelam for Injection by HPLC.Methods Chromatogragy was performed on the Ultimate C18 column(4.6 mm×5250mm,5μm),using methanol-water(5:95)as the mobile phase under the delection wavelength of 214 nm,and the flow rate was 1.0 mL·min-1.Results The linear range of oxiracelam was 0.0404-0.3232 mg·mL-1(r=0.9998).The average recovery rate was 99.6%(RSD=1.0%).Conclusion The method is simple and accurate with good reproducibility,which can be used for the quality control of Oxiracetam for Injection.