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目的建立测定磷酸奥司他韦原料药含量及其有关物质的方法。方法采用HPLC法,用LunaC8柱,流动相为0.05mol·L-1磷酸二氢钾溶液-乙腈-甲醇(620:245:135),流速为1.2mL·min-1,柱温为50℃,检测波长为207nm。结果主峰能与相邻杂质峰较好地分离,磷酸奥司他韦809～1315μg·mL-1的线性关系良好(r=0.9999),平均回收率为100.3%(n=9)。结论所建方法简便、准确、专属性好,可用于磷酸奥司他韦原料药的含量及其有关物质的测定。
OBJECTIVE To establish a method for the determination of oseltamivir phosphate and its related substances. Methods The HPLC method was developed on a Luna C8 column with a mobile phase of 0.05 mol·L-1 potassium dihydrogen phosphate solution-acetonitrile-methanol (620: 245: 135) at a flow rate of 1.2 mL · min- Detection wavelength of 207nm. The results showed that the main peak was well separated from the adjacent impurity peak. The linear relationship between oseltamivir 809 ~ 1315μg · mL-1 was good (r = 0.9999) and the average recovery was 100.3% (n = 9). Conclusion The method is simple, accurate and specific. It can be used for the determination of the content of related substances and the determination of related substances.