摘要
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.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2007年第8期1285-1287,共3页
Chinese Journal of Pharmaceutical Analysis