高效液相色谱法测定富马酸沃诺拉赞的含量

Content Determination of Vonoprazan Fumarate by HPLC

目的:建立富马酸沃诺拉赞的含量测定方法。方法:采用高效液相色谱法,色谱柱为Agilent TC-C_(18)柱(4.6 mm×150 mm,2.5μm),流动相为0.01 mol/L磷酸钠溶液-乙腈(V∶V=75∶25),流速为1.0 ml/min,检测波长为230 nm,进样量为10μl。结果:富马酸沃诺拉赞的线性范围是121.06～282.48μg/ml,线性方程为Y=16 019X-28 538(r=1.000 0);平均加样回收率为100.40%,RSD=0.79%(n=9);6批样品含量测定结果分别为100.2%、100.8%、100.4%、100.6%、100.0%及99.8%。结论:本方法简便、快速且准确,可用于富马酸沃诺拉赞的质量控制。

OBJECTIVE： To establish a method for content determination of vonoprazan fumarate. METHODS： HPLC method was adopted. Agilent TC-C_（18）column（4.6 mm×150 mm, 2.5 μm） was used and the mobile phase was 0.01 mol/L sodium phosphate solution-acetonitrile（V∶V=75∶25）, the flow rate was 1.0 ml/min, the detection wavelength was 230 nm and the sample volume was 10 μl. RESULTS： The linear range of vonoprazan fumarate was 121.06-282.48 μg/ml, the linear equation was Y=16 019 X-28 538（r=1.000 0）, the average sample recovery was 100.40%, RSD was 0.79%（n=9）. The results of 6 batches of samples were 100.2%, 100.8%, 100.4%, 100.6%, 100.0% and 99.8%, respectively. CONCLUSIONS： The method is simple, fast and accurate and can be used for the quality control of vonoprazan fumarate.