高效液相色谱法测定布美他尼片的溶出度

HPLC determination of the dissolution of bumetanide tablets

目的:建立高效液相色谱法测定布美他尼片的溶出度。方法:采用 Alltima C_8色谱柱(4.6 mm×250 mm,5μm),流动相为磷酸盐缓冲液(pH=7.8)-乙腈(70:30),流速1.0 mL·min^(-1),紫外检测波长为216 nm,进样体积为20μL。结果:布美他尼在0.6～1.6μg·mL^(-1)范围内浓度与峰面积呈良好线性关系(r=0.9998);高、中、低3种不同浓度的平均回收率范围为99.0～103.0%;最低检测量为0.01 ng。结论:本法操作简便、准确、专属性强,可满足布美他尼片溶出度质量控制的要求。

Objective：An HPLC method was developed to determine the dissolution of bumetanide tablets. Method：The determination was performed on a Alhima Cscolumn （4.6mm×250mm,5μm） with the mobile phase： phosphate buffer solution（ pH = 7. 8 ） -acetonitrile （70： 30 ）, the flow rate was 1.0 mL· min^ -1 and the detective wavelength was 216 nm, the injection volumn was 20μL. Results： The method offered good linearity from 0. 6 to 1.6μg·mL^- 1 （ r = 0. 9998 ）. The average recovery was from 99.0% to 103.0% for three different levels of the added amount of bumetanide. The minimal detectable concentration of bumetanide was 0. 01 ng. Conclusion：The method is convenient, accurate and specific. It can be used for control of dissolution of bumetanide tablets.