吲达帕胺在释放介质中的稳定性及影响因素

Stability and influencing factors study of Indapamide in release medium

目的:考察吲达帕胺在不同pH介质中的稳定性情况及影响其稳定性的主要因素。方法:采用高效液相色谱法(HPLC),考察不同温度、pH及Fe^(3+)浓度条件下溶液稳定性情况,并考察加入不同稳定剂对于吲达帕胺降解的影响。结果:吲达帕胺在pH 1.0～3.0介质中的降解与t^(1/2)呈线性关系,pH的降低、温度的升高及金属离子(Fe^(3+))的增加会加速吲达帕胺的降解。依地酸二钠或维生素C能有效减少其在酸性溶液下的降解。结论:吲达帕胺溶液在pH 1.0～3.0介质中不稳定,影响其降解的主要因素包括pH、温度和金属离子(Fe^(3+));在pH 4.5、pH 6.8及水介质中稳定。依地酸二钠或维生素C是有效的稳定剂。

Objective: To investigate the stability of indapamide in different pH media and the main factors influencing its stability. Methods : The stability of indapamide solution under the different temperatures, pHs and metal ion( Fe^3+) concentrations was tested by HPLC method, and the effects of different stabilizing agents influencing degradation of indapamide were investigated. Results: It was found that the degradation of indapamide was linearly related to t^1/2 in pH 1.0-3.0 media. The degradation rate was accelerated with the decrease of pH , increase of temperature and increase of metal ion ( Fe^3+) concentration. Disodium edetate or vitamin C could reduce its degradation in the acid solution effectively. Conclusion: The Indapamide solution was unstable in the pH 1.0-3. 0 media, and the main factors influencing its degradation are pH , temperature and metal ion ( Fe^3+). It was stable in pH 4. 5 , pH 6. 8 and aqueous media. Disodium edetate or vitamin C can be an effective stabilizing agent.