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-C18 column(250 mm× 4.6 mm,5 μm) with mobile phase acetonitrile (0.02％ formic acid)-water (0.02％ formic acid) =60 ∶ 40 (V/V) at the flow rate of 1.0 mL/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 30 mg/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.%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-C18(250 mm×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1.0 mL/min的流速进行洗脱,检测波长为195 nm,柱温为30℃,进样量为100 μL.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.
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