HPLC法测定盐酸普拉克索平衡溶解度和表观油水分配系数

Determination of equilibrium solubility and apparent oil/water partition coefficient of pramipexole dihydrochloride by HPLC

目的测定盐酸普拉克索在不同介质中的平衡溶解度及其在正辛醇-水/缓冲溶液体系中的表观油水分配系数,为设计盐酸普拉克索新剂型提供依据。方法采用摇瓶-高效液相色谱法测定盐酸普拉克索在水中和不同p H值缓冲液中的平衡溶解度及表观油水分配系数。结果 37℃时盐酸普拉克索在水中的平衡溶解度为570 g·LP^(-1)P,平衡溶解度随p H值的增大而变小,表观油水分配系数随p H值的增大而增大。结论 37℃时盐酸普拉克索易溶于水,p H值影响平衡溶解度和油水分配系数,但变化趋势都较小。

Objective To determine the equilibrium solubility of pramipexole dihydrochloride in various medium and its apparent oil/water partition coefficient partition coefficient in the n-octanol-water/buffer solution systems, which will provid a basis for design new formulations. Method A shake flask- high performance liquid chromatography(HPLC) method was established to determine the equilibrium solubility and apparent oil/water partition coefficient of pramipexole dihydrochloride in water and different p H buffer solutions. Result The equilibrium solubility of pramipexole dihydrochloride was 570 mg·LP^(-1) Pin water at 37 ℃ and the p H of the buffer solution had no influence on its equilibrium solubility. With the increase of solution p H, apparent oil/water partition coefficient of pramipexole dihydrochloride was also rising. Conclusion The method established in this paper can successfully used to determine the equilibrium solubility and the apparent oil/water partition coefficient of pramipexole dihydrochloride.