文摘
stability-indicating高性能薄层色谱方法的开发和验证的估计Naftopidil散装和制药配方
作者(年代):注:Jain,降低价格Bobade, S.J.Surana一个简单的、有选择性的、精确的和Stability-indicatingHigh-performance thinlayer Naftopidil的色谱分析方法在批量和制药配方开发和验证。方法采用,HPTLCaluminiumplates预镀以硅胶为固定相。己烷溶剂系统包括:乙酸乙酯:冰醋酸(4:4:2 v / v)。systemwas发现给紧凑点Naftopidil (Rf 0.43±0.02)的价值。光密度分析Naftopidil进行吸光度的模式在253海里。标定块的线性回归分析数据显示良好的线性关系,r2 = 0.999±0.0001对峰面积在200 - 1200 ng /浓度范围。精度的方法验证,复苏和鲁棒性。检测和量化的极限是20.35和61.68 ng /现货,分别。Naftopidil受到酸和碱水解、氧化和热降解。药物发生降解酸性下,基本的、氧化和热条件。 This indicates that the drug is susceptible to acid, base, oxidation and thermal conditions. 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 identification and quantitative determination of Naftopidil in bulk drug and pharmaceutical formulation.
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