摘要

测定原料药和制剂中芦藤苷稳定性指示HPTLC方法的建立与验证

作者(年代):P.S.Jain, Tulsidas R.Lohar, Swapnil N.Patil, S.J.Surana

建立了一种简单、选择性、精确、稳定的高效薄层色谱法(HPTLC)，用于原料药和制剂中芦藤苷的分析。该方法采用硅胶60 F254预涂dhptlc铝板作为固定相。溶剂体系为甲苯:甲醇:乙酸(4:1.5:0.5 v/v/v)。结果表明，该体系可为芦多苷提供致密的斑点(Rf值为0.40±0.02)。在366 nm的吸光度模式下对芦藤苷进行了密度分析。校正图的线性回归分析数据与浓度范围700Â - 1200 ng /点的峰面积呈良好的线性关系，r2 = 0.999±0.0015。相对于峰面积，斜率和截距的平均值±SD分别为5.2599±1.47和2899.5±1.78。验证了该方法的精度、回收率和鲁棒性。检出限为27.99 ng /点，定量限为84.83 ng /点。芸香苷经过酸、碱水解、氧化、光降解和热降解。 The drug undergoes degradation under acidic, basic and light exposure conditions. This indicates that the drug is susceptible to acid, base and light (Photo degradation). The degraded product was well resolved from the pure drug with significantly different Rf value. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of investigated drug. The proposed developed HPTLC method can be applied for the identification and quantitative determination of Rutoside in bulk drug and pharmaceutical formulation.