摘要
为建立HPLC-UV测定奥贝胆酸片含量的方法,采用高效液相色谱法及紫外检测器,色谱柱为Agilent HC-C_(18)(250mm×4.6mm,5μm),流动相为乙腈(含0.02%(体积分数)甲酸)-水(含0.02%(体积分数)甲酸),二者体积比为60∶40,以1.0mL/min的流速进行洗脱,检测波长为195nm,柱温为30℃,进样量为100μL。结果表明:奥贝胆酸质量浓度在0.200 26~1.001 30mg/mL范围内与峰面积呈良好的线性关系,相关系数r=0.999 9;中间精密度、稳定性、重复性试验的RSD值不超过1.0%;平均回收率为99.64%,RSD值为0.58%(n=9)。该方法简便、专属性好、精密度高、耐用性良好,可用于奥贝胆酸片含量的测定。
In order to establish a method for the content determination of obeticholic acid tablets,HPLC-UV method is adopted.The determination is performed on Agilent HC-C18column（250mm×4.6mm,5μm）with mobile phase acetonitrile（0.02%formic acid）-water（0.02%formic acid）= 60∶40（V/V）at the flow rate of 1.0mL/min.The detection wavelength is 195 nm,the column temperature is 30 ℃ and the volume is 100μL.The result shows that there is a good liner relationship between the mass concentration of obeticholic acid in the range of 0.200 26～1.001 30mg/mL and the peak area,and r=0.999 9.The RSD of precision,stability and reproducible tests are all less than 1.0%.The average recovery rate is 99.64%,and RSD is 0.58%（n=9）.The method is simple,exclusive,accurate and durable,and can be used for the content determination of obeticholic acid tablets.
出处
《河北科技大学学报》
CAS
2017年第2期158-162,共5页
Journal of Hebei University of Science and Technology
基金
河北省人力资源和社会保障厅择优资助项目(C201400317)
