目的 考察帕拉米韦原料药在不同条件下的稳定性。方法 采用高效液相色谱法。Welch ODS C₁₈色谱柱（250 mm×4.6 mm，5 μm）；流动相水（含0.1%冰醋酸）-乙腈（90：10）；检测波长210 nm；体积流量1.0 mL/min；柱温：25℃；进样量10 μL。考察了帕拉米韦原料药在不同温度、光照和不同pH值下的稳定性。结果 帕拉米韦原料药在100℃条件下48 h内是稳定的；在光照10 d的情况下，帕拉米韦的稳定性良好；帕拉米韦在碱性和中性环境下稳定性良好，在酸性条件下不稳定，随着pH值的降低，稳定性越差，在pH 1.0时，降解半衰期（t_1/2）是43.6 h。结论 帕拉米韦在酸性环境中极不稳定，在碱性和中性条件下稳定性良好。

Objective To investigate the stability of peramivir active pharmaceutical ingredient at the different conditions. Methods HPLC method was established. The method was performed on Welch ODS C₁₈column (250 mm×4.6 mm, 5 μm) using a mobile phase consisting of water (0.1% glacial acetic acid)-acetonitrile (90:10). The detection wavelength was set at 210 nm and the flow rate was 1.0 mL/min. The column temperature was 25℃, and volume of injection was 10 μL. The stabilities of peramivir active pharmaceutical ingredient were investigated at the different temperatures, under lighting, and in the buffers with different pH. Result Peramivir active pharmaceutical ingredient was stable for 48 h when incubated at 100℃, and after lighting for 10 d. Peramivir active pharmaceutical ingredient was stable under neutral and alkaline pH, but it was not stable in the acidic environment. The t_1/2was 43.6 h when incubated in phosphates buffers with pH 1.0. Conclusion Peramivir is extremely unstable in acidic environment, and is stable under alkaline and neutral conditions.

国家自然科学基金资助项目（81560577，81360485）