磷酸奥司他韦胶囊稳定性研究

Stability Study of Oseltamivir Phosphate Capsules

目的考察国内抗流感药品磷酸奥司他韦胶囊的质量稳定性。方法采用高效液相色谱法（HPLC）[Phenomenex Cs（2）色谱柱，流动相为0．05mol·L^-1磷酸二氢钾溶液一乙腈．甲醇（620：135：245），检验波长207nm，流速1．0mL·min^-1，柱温50℃]对国内16批磷酸奥司他韦胶囊进行了质量稳定性研究，跟踪分析了药品储存前后及相关样本加速实验的杂质变化情况。结果16批药品的总杂质含量储存前后分别为0．11％～0．29％和0．15％～0．71％，加速实验预测并证实了这种变化趋势。结论国内磷酸奥司他韦胶囊药品化学质量稳定性较好，但也存在一定的差异性。

OBJECTIVE To study the stability of domestic osehamivir phosphate capsules. METHODS HPLC method was used to study the stability of sixteen batches of osehamivir phosphate capsules. Phenomenex Cs （2） column was used with UV detection at 207 nm, and the mobile phase consisted of phosphoric buffer（0.05 mol·L^-1 KH2 PO4）, methanol and acetonitrile （620： 135： 245）, the flow rate was 1.0 mL · min^-1, and the column oven was maintained at 50℃. The contents of impurities before and after storage and in accelerated condition were tracked. RESULTS The total impurity contents before and after storage were 0. 11% - 0. 29% and 0. 15% -0. 71% , respectively, and the accelerated test data confirmed the change trend. CONCLUSION The domes- tic osehamivir phosphate capsules are stable in chemical quality, but there exists some differences between products from different man- ufacturers.