目的建立奥拉西坦注射液中奥拉西坦的含量测定方法。方法高效液相色谱法,用氨基硅烷键合硅胶为填充剂,流动相为乙腈-水(体积比80∶20),检测波长210 nm。结果奥拉西坦质量浓度在0.025~0.20 mg/mL范围内与峰面积呈良好的线性关系(r=1.0000);精密度、重复性试验结果RSD分别为0.10%和0.30%;平均回收率为100.85%,RSD=0.79%。结论本法简便,灵敏,准确,重现性好,建立的定量方法可用于控制该注射液的质量。 Objective To establish a method for the determination of oxiracetam in oxiracetam injection. Methods High performance liquid chromatography (HPLC) was performed using aminosilane bonded silica as the filler. The mobile phase was acetonitrile - water (80:20 by volume) and the detection wavelength was 210 nm. Results The oxiracetam concentration ranged from 0.025 to 0.20 mg / mL and showed a good linear relationship with the peak area (r = 1.0000). The RSDs of precision and repeatability were 0.10% and 0.30%, respectively. The average recoveries were 100.85%, RSD = 0.79%. Conclusion This method is simple, sensitive, accurate and reproducible. The established quantitative method can be used to control the quality of the injection.