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目的:建立以高效液相色谱法测定托拉塞米缓释微丸胶囊含量及其有关物质的方法。方法:色谱柱:WatersRP_(18)(250 mm×4.6 mm,5μm),流动相:甲醇-0.02 mol·L~(-1)磷酸二氢钾溶液(55:45),检测波长:291 nm,流速:1 ml·min~(-1),柱温:30℃。结果:托拉塞米在2.51～15.06μg范围内进样量与峰面积呈良好的线性关系(r=0.999 5);平均回收率为99.87%(RSD=0.2%)。结论:本方法简便、准确、专属性强,可用于该制剂的质量控制。
Objective: To establish a HPLC method for the determination of torsemide sustained-release pellets and its related substances. METHODS: The mobile phase was WatersRP_ (18) (250 mm × 4.6 mm, 5 μm). The mobile phase was methanol-0.02 mol·L -1 potassium dihydrogen phosphate solution (55:45) Flow rate: 1 ml · min ~ (-1), column temperature: 30 ℃. Results: There was a good linear relationship between the injected volume and the peak area of torasemide in the range of 2.51 ~ 15.06μg (r = 0.999 5). The average recovery was 99.87% (RSD = 0.2%). Conclusion: The method is simple, accurate and specific and can be used for the quality control of the preparation.