地塞米松磷酸钠滴眼液的稳定性考察

目的:考察地塞米松磷酸钠滴眼液的稳定性,预测其有效期。方法:采用高效液相色谱法测定地塞米松磷酸钠滴眼液中地塞米松磷酸钠的含量,以初匀速法预测其稳定性。结果:地塞米松磷酸钠检测浓度的线性范围为18~70μg.mL-1(r=0.999 9),平均回收率为99.74%,RSD=0.37%;滴眼液随温度的升高以及存放时间延长其含量下降,但pH变化不明显。计算得25℃时其有效期为70d,4℃冷藏其有效期可延长至438d。结论:本品4℃存放稳定性较好。

Stability of Dexamethasone Sodium Phosphate Eye Drops

OBJECTIVE： To study the stability of dexamethasone sodium phosphate（DSP） eye drops and predict its validity duration. METHODS： The content of DSP in eye drops was determined by HPLC and its validity duration was predicated using initial average rate method. RESULTS： The linear concentration range of DSP was 18--70 μg· mL^-1（r = 0.999 9） with an average recovery rate of 99.74% （RSD = 0.37%）. The content of DSP in the eye drops decreased as its storing temperature increased and the storing time prolonged, but its pH was stable. The validity duration of the eye drops was computed to be 70 days at 25 ℃ and 438 days at 4 ℃ . CONCLUSION： This eye drops were stable at 4℃ .