文摘

开发和验证stability-indicating高效能的薄层色谱方法对估计cilostazole散装和制药配方

作者(年代):Mujeeb G。汗,另外Jain, S.J.Surana

简单、选择性、精确和Stability-indicatingHigh-performance thinlayer色谱方法分析Cilostazole在批量和制药配方开发和验证。方法采用,效果预镀铝盘子以硅胶为固定相。的溶剂系统是由甲苯:乙酸乙酯:甲醇:氨(3.5:2:0.8:0.3 v / v / v)。系统被发现给Cilostazole紧凑点(Rf 0.52±0.02)的价值。光密度分析Cilostazole进行吸光度的模式在258海里。标定块的线性回归分析数据显示良好的线性关系,r2 = 0.992±0.0001对峰面积在300 - 1800 ng /浓度范围。均值±s.d斜率和截距分别为4.6809±0.005,2284.4±4.20对峰面积。精度的方法验证,复苏和鲁棒性。极限的检测和quantificationwere 15.69和45.07 ng /现货,分别。Cilostazole受到酸和碱水解、氧化和热降解。 The drug undergoes degradation under acidic and basic conditions. This indicates that the drug is susceptible to acid and base. The degraded product was well resolved fromthe 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 Cilostazole in bulk drug and pharmaceutical formulation.