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摘要：目的 本实验采用HPLC法测定左乙拉西坦片的杂质、含量及溶出度。 方法 采用HPLC法测定左乙拉西坦片的杂质、含量和溶出度。结果 样品中有关物质占0.01267%，杂质C和杂质D几乎为零。左乙拉西坦检测限为12.5 μg/mL，定量限为25.0 μg/mL。左乙拉西坦在0.025～0.5 mg/mL范围内浓度与峰面积线性关系良好。A= 46077.9C-147.0，r = 0.9999 （n = 5）。精密度RSD值为0.22%，0.15%，0.42%，符合要求。稳定性RSD值为0.76%，符合要求。样品高、中、低三个浓度的含量平均回收率为100.1%，100.3%，100.8%，符合测定要求。样品的含量达到了99.87%，在98.0%～102.0%范围之内，符合原料药的质量要求。溶出度在9分钟完全释放。各项结果均符合标准质量条件。结论 本法简单、准确、可靠，适用于左乙拉西坦片的含量测定。7223
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关键词：左乙拉西坦片；HPLC；杂质；含量；溶出度。
Study on The Quality Standards of Levetiracetam Tablets
Abstract: Objectives To establish an HPLC method for the determination of levetiracetam and its impurities,content and dissolution rate. Method To establish an HPLC method for the determination of levetiracetam and its impurities,content and dissolution rate. Results The batches of related substances is 0.01267% . Impurity C and impurity D is almost zero. The detection limit of levetiracetam was 12.5 μg / mL, limit of quantitation of levetiracetam was 25.0 μg / mL. Levetiracetam of 0.025 ~ 0.5 mg / mL range of concentrations good linear relationship of peak area. A= 46077.9C-147.0, r = 0.9999 （n = 5）. Precision measurement RSD of 0.22%，0.15%，0.42%, to meet the requirements. Stability measured with RSD of 0.76%, to meet the requirements. The batches of samples, recovery was 100.1%,100.3% and 100.8%, in line with the determination of requirements. The content of the batches of samples were 99.87%, was 98.0% ~ 102.0% within the scope of the drug substance quality requirements. Dissolution rate was completely released in the 9th minute. All outcomes were conform to the standard quality requirements.Conclusion The method is simple, accurate and reliable determination of Levetiracetam.
Keywords: Levetiracetam ; HPLC method ; impurities ; content ; dissolution rate.
目录
1 绪论 - 1 -
1.1 癫痫 - 1 -
1.1.1 发病机制 - 1 -
1.1.2 癫痫的治疗 - 2 -
1.2 左乙拉西坦的文献综述 - 3 -
1.2.1 物理性质和化学性质 - 3 -
1.2.2 药理作用 - 3 -
1.2.3 药代动力学 - 3 -
1.2.4 临床研究 - 5 -
1.3 课题研究的意义 - 6 -
2 实验内容 - 7 -
2.1仪器与试药 - 7 -
2.2 高效液相色谱法检测左乙拉西坦片中的杂质 - 7 -
2.2.1有关物质 - 8 -
2.2.2杂质C - 11 -
2.2.3 杂质D - 15 -
2.3高效液相色谱法检测左乙拉西坦片的含量 - 19 -
2.3.1 色谱条件 - 19 -
2.3.2 系统适用性试验 - 19 -
2.3.3 专属性实验 - 19 -
2.3.4 检测限、定量限试验 - 21 -
2.3.5 标准曲线 - 21 -
2.3.6 精密度实验 - 22 -
2.3.7 溶液稳定性试验 - 22 -
2.3.8 含量回收率实验 - 23 -
2.3.9 含量测定 - 23 -
2.4 高效液相色谱法测定左乙拉西坦片的溶出度 - 25 -
2.4.1 色谱条件 - 25 -
2.4.2 系统适应性试验 - 25 -
2.4.3 专属性实验 - 25 -