HPLC法测定阿尼西坦缓释片中的含量

Determination of Sustained-release Tablets of Aniracetam by HPLC

目的：建立HPLC法测定阿尼西坦缓释片含量的质量标准。方法：采用高效液相色谱法测定阿尼西坦缓释片含量,色谱柱：十八烷基硅烷键合硅胶为填充剂（150mm×4.6mm,5μm）;流动相：乙腈-水（35：65）;流速：1m L/min;柱温：30℃;检测波长：282 nm;进样量：20μL。结果：阿尼西坦缓释片含量测定的回归方程为：Y=23.176X＋21.312（n=0.9999）。阿尼西坦的浓度在60.24~140.56μg/m L范围内与峰面积具有良好的线性关系。平均回收率为97.79%（RSD=0.70%,n=9）。结论：该法重现性好,专属性强,方便准确,可用于阿尼西坦缓释片的质量标准控制。

Objective：To establish an HPLC method for the determination of quality standards Aniracetam - release Tablets. Methods： Determined by high performance liquid chromatography Aniracetam sustained release tablets, Column： octadecyl silane bonded silica as a filler column （ 150mm×4.6mm, 51μm） ; mobile phase： acetonitrile - water （35：65） ; flow rate： lmL/min; column temperature： 30% ; detection wavelength： 282nm; injection volume：20μL. Results：The regression equation Aniracetam determination of sustained -release tablets： Y =23. 176X ＋ 21. 312, r = 0. 9999. The concentration of aniracetam in the 60.24 - 140.56μg/mL range with good linear relationship between peak area. The average recovery rate was 97.79% （RSD = 0.70%, n = 9）. Conclusion：The method with good reproducibility, specific, easy and accurate for quality control standards Aniracetam Sustained Release Tablets.