HPLC测定磷酸奥司他韦原料药的含量并检测其有关物质

Determination of Oseltamivir phosphate and its related substances by HPLC

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 an HPLC method for the determination of Oseltamivir phosphate and its related substances. METHODS The chromatographic determination of Oseltamivir phosphate was operated on Luna Cs column with a flow rate of 1.2 mL·min^-1 of the mobile phase consisting of phosphate buffer （ 0.05 mol·L^-1 potassiam dihydrogen phosphate） - acetonitrile - methanol（620 ： 245 ： 135 ）. The detection wavelength was set at 207 nm, and the column oven was maintained at 50℃. RESULTS Osehamivir phosphate was completely separated from impurities. The calibrated linear curve of Osehamivir phosphate was within 809 - 1315 μg·mL^-1（r =0.9999）,the average recovery was 100.3% （n = 9）. CONCLUSION A simple, rapid and sensitive HPLC method for determination of Osehamivir phosphate and its related substances was established.