经典恒温加速法预测酮替芬水溶液的稳定性

Estimation of the stability of ketotifen by classic isothermal accelerated tests

采用恒温加速实验法，研究了温度对酮替芬水溶液稳定性的影响。结果显示，在ｐＨ７．０．２５℃时水溶液中的酮替芬分解１０％的时间为６．５ｈ：而在ＰＨ５．０以下．９０℃时，水溶液中的酮替芬含量２４ｈ内未见明显变化，说明酮替芬水溶液在ｐＨ５．０以下稳定。

The stability of ketotifen was estimated by using classic isothermal accelerated tests at 5 different temperatures. Samples were taken at certian time intervals and the content of ketotfen was determined by using HPLC. The result showed that it was 6.5h for ketotifen to be decomposed by 10 per cent in the water solution wich pH7.0 at 25℃. The content of ketotifen in soJution did not change significantly when pH was below 5.0 and temperature was 90℃ at 24h. Thercfore, ketotifen was stable under the condition of pH≤5.0