摘要
目的建立RP-HPLC方法测定注射用吡拉西坦含量及有关物质。方法采用Hypersil C18（4．6×250mm，10μm）色谱柱，甲醇-水（10：90）为流动相，检测波长：215nm。结果吡拉西坦在4．73～75．68mg／mL浓度范围内，峰面积与浓度呈良好线性关系（γ=0．9999），平均回收率为99．86％～100．51％，RSD=0．72％～1．23％％。吡拉西坦及其有关物质达到基线分离，最低检测量为0．01ng，控制总杂质量不得超过1．0％。结论用本法测定吡拉西坦的含量及有关物质，方法简便、快速、结果准确，专属性好，适用于吡拉西坦及其制剂的质量控制。
Objective To establish a RP-HPLC method for the determination of piraeetam for injection and its related substances. Methods A RP-HPLC method was developed： Chromatographic condition included a Hypersil C18 colunm with the mobile phase of methanol and water （10：90）. The UV detection wavelength was set up at 215nm. Results The linearity of piraeetam was shown in range of 4.73～75.68mg/mL （γ=0.9999）.The recovery rate was 99.86%-100.51% with RSD=0.72%～1.23 %o The peak of piracetam and its related substances were separated completely. The LOD was in 0.01ng. Conclusion The simple and reliable method in the study could be applied to quantify piracetam for injection and its relevant substances and be used to control piracetam and its preparations.
