高效液相色谱法测定布美他尼片的溶出度

Determination of dissolution of bumetanide tablets by HPLC

目的建立测定布美他尼片溶出度的新方法。方法采用高效液相色谱法,使用C18反相柱Phenom enex(4.6×250mm,5μm);流动相:甲醇-水(75∶28)含1%的甲酸;流速:1.0ml.min-1;检测波长:267nm。结果在该条件下,在0.038μg^0.608μg范围内,线性关系良好(r=0.99999)。样品平均回收率为98.1%(n=5),RSD=0.25%。结论该方法简便、准确、专属性好,可用于布美他尼片的质量控制。

OBJECTIVE To set up a new method to determine the dissolution of bumetanide tablets. METHODS In an HPLC assay, a kontron phenomenex column （4.6 × 250mm, 5μm） ; was used ; the mobile phase was methanol-water（75： 28）with the addition of 1% v/v formic acid;the flow rate was 1.0ml · min^-1; the wavelength was set at 267nm. RESULTS Under these conditions the calibration curve was linear in the range of 0. 038μg～0. 608μg. The average recovery was 98.1% with RSD of 0.25%. CONCLUSION The method had the advantage of simplicity, accuracy and reliability, and it may be used for quality control of bumetanide tablets.