A binary mixture of Silymarin (SR) and Vitamin E (VE) acetate, of an antioxidant and a hepatoprotective effect, has been analyzed using a sensitive, selective and economic high performance thin layer chromatographic (HPTLC) method in their pure forms, pharmaceutical formulation and spiked human plasma. SR and VE were separated on 60F254 silica gel plates using hexane:acetone:formic acid (7:3:0.15, v/v/v) as a developing system with UV detection at 215 nm. The method was evaluated for linearity, accuracy, precision, selectivity, limit of detection (LOD) and limit of quantification (LOQ). SR and VE were detected in the linear range of 0.2-2.5 and 0.2-4.5 μg/band, respectively. Method validation was done as per ICH guidelines and acceptable results of accuracy of 99.86 ± 1.190 and 100.22 ± 1.609 for SR and VE, respectively were obtained. The method has been successfully applied for determination of the studied drugs in their pharmaceutical formulation without any interference from excipients, and in spiked plasma samples. Results obtained by the developed HPTLC-densitometric method were statistically compared to those obtained by the reported HPLC methods and no significant difference was found between them.

中文翻译：

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药物制剂和人血浆中保肝组合的HPTLC分离。

使用灵敏，选择性和经济的高效薄层色谱法（HPTLC）以纯净形式，药物制剂的形式分析了水飞蓟素（SR）和醋酸维生素E（VE）的二元混合物，具有抗氧化剂和保肝作用。并掺入人体血浆。SR和VE在60F254硅胶板上分离，使用己烷：丙酮：甲酸（7：3：0.15，v / v / v）作为显影系统，并在215 nm处进行UV检测。评价了该方法的线性，准确性，精密度，选择性，检测限（LOD）和定量限（LOQ）。SR和VE的线性范围分别为0.2-2.5和0.2-4.5μg/ band。按照ICH指南进行方法验证，得出SR和VE的准确度分别为99.86±1.190和100.22±1.609的可接受结果。该方法已成功地用于确定药物制剂中所研究药物的状态，而不受赋形剂的干扰以及加标血浆样品中的药物。将通过开发的HPTLC密度法获得的结果与通过报告的HPLC方法获得的结果进行统计比较，发现两者之间没有显着差异。