HPLC法测定托拉塞米口服制剂的含量

Determination of Torasemide in Torasemide Oral Preparation by HPLC

目的：建立高效液相色谱法测定托拉塞米片剂和胶囊中托拉塞米的含量的方法。方法采用 Phenomenex Luna C18（250mm×4.6mm，5μm）色谱柱，以0.1％三乙胺（用磷酸调节pH至3.5）-甲醇（55∶45）为流动相，流速为1.0mL·min -1，检测波长为291nm。结果托拉塞米在20.06～401.16μg· mL -1范围内浓度与峰面积呈良好的线性关系（r＝0.9999），片剂平均回收率为99.90％，RSD为0.52％（n＝9）；胶囊平均回收率为100.26％，RSD为0.34％（n＝9）。结论本方法简便、快速，结果准确，重现性较好。

OBJECTIVE To establish a method for determination content of Torasemide in Torasemide Tablet and Torasemide Capsules by HPLC.METHODS Phenomenex Luna C18（250mm ×4.6mm,5μm）column was used and 0.1%Triethylamine-methanol （55∶45） was used as mobil phase ,the flow rate was 1.0mL·min -1 ,the detecting wavelength was at 291 nm.RESULTS There was a good linear relationship between the concentration of to-rasemide and peak area within a range of 20.06-401.16μg· mL-1 （ r=0.9999 ）.The average recover of tablet was 99.90%,with RSD=0.52%（ n=9 ）;The average recover of capsule was 100.26%, with RSD=0.34%（ n=9 ）.CONCLUSION The method is simple ,highly repeatable and accurate.