【摘 要】
：
目的研究苯扎贝特在光照,高温,酸,碱,氧化等条件下,可能发生的降解。方法根据欧洲药典5.0中苯扎贝特有关化合物的HPLC测定方法,以百分面积法计算主成分含量和杂质含量。结果
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目的研究苯扎贝特在光照,高温,酸,碱,氧化等条件下,可能发生的降解。方法根据欧洲药典5.0中苯扎贝特有关化合物的HPLC测定方法,以百分面积法计算主成分含量和杂质含量。结果苯扎贝特在碱性条件下非常容易发生降解,在氧化条件和酸性条件下也会发生降解;在高温和光照条件下相对比较稳定。结论苯扎贝特(EP5.0)相关物质的分析方法,具有稳定性、指示性,能分离和检测到产品中可能产生的降解产物。
Objective To study the possible degradation of bezafibrate under light, high temperature, acid, alkali and oxidation conditions. Methods According to the method of HPLC for the determination of bezafibrate in European Pharmacopoeia 5.0, the content of main components and the content of impurities were calculated by percentage area method. Results bezafibrate was easily degraded under alkaline conditions and degraded under both oxidative and acidic conditions and relatively stable under high temperature and light conditions. Conclusion The analytical method of bezafibrate (EP5.0) related substances has stability and indication, and can separate and detect the possible degradation products in the product.
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