高效液相色谱法测定托拉塞米片中托拉塞米及其有关物质的含量

目的:建立高效液相色谱法测定托拉塞米片中托拉塞米及其有关物质的含量。方法:以岛津ShimpackCLC(M)C18(250mm×4.6mm,5μm)为色谱柱;以甲醇-0.02mol·L-1磷酸二氢钾溶液(用磷酸调节pH至3.0)(65∶35)为流动相;UV检测波长291nm;流速0.9mL·min-1。结果:托拉塞米在2～24mg·L-1范围内具有良好线性关系(r=0.9999),平均加样回收率为99.73%,RSD为0.17%(n=9);3批样品的标示百分含量(%)分别为99.80,100.10,100.40,有关物质的百分含量分别为0.58,0.45,0.39。结论:本方法准确、灵敏,重现性好,可用于托拉塞米片及其有关物质的含量测定。

Determination of torasemide and its related substances in toraesmide tablets by high performance liquid chromatography

AIM: To establish the HPLC for determining torasemide and its re lated su bstances in torasemide tablets. METHODS: The HPLC was performed on Shimpack CLC(M)C_(18)(250 mm×4.6 mm,5 μm) column. The mobile phase consisted of met han ol and 0 .02 mol·L~(-1) monobasic potassium phosphate buffer(65 ∶35). The flow rate was 0.9 mL ·min~(-1). The detection wavelength was set at 291 nm. RESULTS: The assay showed good linea r correlation over the range of 2-24 mg·L~(-1) (r=0.999 9). The average recovery rate was 99.73 %,with the RSD= (0.17 %) (n=9). The concentrotions of torasemide in torasemide tablets wer e 99.8 0 %,100.10 %,(100.40 %) and the related substances in torasemide tablets were 0.58 %,0.45 %,0.39 % ,respec tively. CONCLUSION: The HPLC is accurate,sensitive and repeatable with val uabl e application to the quality control of torasemide tablets.