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发展稳定的指示效果方法Racecadotril从原料药及其剂型

作者(年代):a . s . Gadekar诉诉潘德,j . r . Rao, k . v . Shastri

一个简单的、有选择性的、精确的和stability-indicating高性能薄层色谱法分析racecadotril散装药品及其剂型的开发和验证。方法采用默克效果铝60张硅胶f254作为固定相。的溶剂体系由氯仿:甲醇(9.8:0.2 v / v)。这个系统被发现给racecadotril紧凑点(Rf 0.61±0.02)。Racecadotril受到酸和碱水解、氧化、光降解,降解产品分离纯药物。光密度分析racecadotril缓解-吸光度进行模式在232海里。校准块显示的线性回归分析数据用回归系数值线性关系好,r2 = 0.9994的浓度范围100 - 1000 ng /现货。相关系数的平均值,斜率和截距分别为0.9995±1.88,0.352±0.02,5.205±0.05,分别。检测和定量的限制是200和600 ng /点,分别。该方法精度验证按我的指导方针,复苏和鲁棒性。乐动KENO快乐彩 Racecadotril samples on being degraded with hydrogen peroxide showed additional peaks at Rf 0.006 and 0.64 while the drug on being subjected to acidic and basic hydrolysis showed additional peaks at Rf 0.50 and 0.18, respectively. This indicates that the drug is susceptible to acid-base hydrolysis degradation, oxidation and photochemical degradation. Statistical analysis proves that the method is reproducible and selective for the estimation of the said drug. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one.