高效液相色谱法测定复方奥美拉唑干混悬剂中的有关物质及奥美拉唑磺酰化物的含量

HPLC determination of relevant substances and omeprazole sulphone in compound omeprazole powder for oral suspension

目的建立复方奥美拉唑干混悬剂中有关物质及奥美拉唑磺酰化物的测定方法。方法色谱柱：Agilent-C8（4.6 mm×200 mm,5μm）;流动相：0.01 mol.L-1磷酸氢二钠（用磷酸调节pH值至7.6）-乙腈（75∶25）;检测波长：280 nm;流速：1.0 mL.min^-1;柱温：40℃;进样量：20μL。结果奥美拉唑磺酰化物在0.2~1.0μg.mL-1与峰面积呈良好的线性关系（r=1.0,n=5）。平均回收率99.6%,RSD=0.2%（n=6）。结论本方法简便、迅速、准确。

Objective To establish an HPLC method to determine the relevant substances and omeprazole sulphone in compound omeprazole powder for oral suspension.Methods Agilent-C8 column（4.6 mm×200 mm,5 μm） was used at 280 nm,the mobile phase consisted of 0.01 mol·L-1 dibasic sodium phosphate（adjusted to pH 7.6 with phosphate acid）-acetonitrile（75∶25）,the flow rate was 1.0 mL·min^-1,the column temperature was 40 ℃,and the injection volume was 20 μL.Results There was good linearity for omeprazole sulphone at 0.2-1.0 μg·mL-1（r=1.0,n=5）.The average recovery was 99.6%（n=6）,RSD=0.2%.Conclusion The method is simple,efficient and accurate.