HPLC法测定布美他尼片的含量及含量均匀度

PLC Determination of Content and Content Uniformityof Bumetanide Tablets

建立高效液相色谱法测定布美他尼片的含量及含量均匀度。以KromasilODS柱为分析柱(4.6×250mm,5μm);流动相:乙腈—0.05mol·L-1磷酸二氢钾(用磷酸调PH=3.0±0.5)(50:50);流速:1.0mL·min-1;紫外检测器,检测波长为267nm。布美他尼的浓度在20～60μg·mL-1范围内与峰面积呈良好的线性关系,r=0.9994,最低检测限为0.05μg,平均回收率为100.1%。本法专属性强,操作简便,结果准确。

Objective A HPLC method was developed to determine bumetanide content and its uniformity in tablets. The analytical column was a KromasilODS column（4.6 × 250mm,size：5μm）;The mobile phase consisted of Acetonitrile-0.05mol·L^-1 postassium dihydrogan phospate（adjusted to pH3.0 with phosphori acid）（50：50）and the flow rate of 1.0mL·min^-1.the detection was carried out with UVdetector and the detection wavelength of 267 nm was specified. Under this condition there was a good linear relationship in the concentration range of 20 - 60 μg·mL^-1, the correlation coefficient is 0.9994, the least detective limit was 0.05ng,the average recovery. was 100.1%. The proposed method is selective,simple and accurate. Therefore,the quality of bumetanide tablets can be effectively controlled.