吡拉西坦片溶出度测定方法研究

Study on Determination Method of Dissolution of Piracetam Tablets

目的：建立吡拉西坦片溶出度测定方法。方法：采用浆法，以水为溶剂，转速为100 r/min，20 min 时取样。以高效液相色谱法，C18柱（4.6 mm ×250 mm，5μm）为固定相，以甲醇-水（10：90）为流动相，测定吡拉西坦的溶出度，检测波长为210 nm，流速为1.0 mL/min。结果：吡拉西坦在0.05-0.15 mg/mL 的浓度范围内，线性关系良好。线性方程为：A =1939.5C ＋374.45（r =0.9993）测定吡拉西坦平均回收率为99.5%（RSD =0.44%，n =12）。结论：增加吡拉西坦溶出度检查项极为必要。本方法操作简便，结果正确，为完善吡拉西坦片的质量标准提供有效手段。

Objective： To establish a method for the dissolution determination of piracetam tablets. Methods：Slurry method was adopted using water as solvent, rotate speed was 100 r/min, sampling after 20 min. The dissolu-tion was analyzed by HPLC method. A C18（4.6 mm×250 mm, 5 μm）colum was used as stationary phase with methanol water （10：90） as a mobile phase. The wavelength for detection was at 210 nm. The flow rate was 1.0 mL/min. Re-sults： There was a good linear relationship of piracetam within the range of 0.05 ~ 0.15 mg/mL, A = 1 939.5C ＋374.45 （r = 0.999 3）. The average recovery rate was 99.5% （RSD = 0.44%,n = 12）. Conclusion： It is necessary to set up the method for dissolution determination of piracetam tablets. The method is convenient and accurate. It pro-vides an effective means for the improvement of the quality standard of piracetam tablets.