Development and validation of HPTLC method for simultaneous estimation of berberine, gallic acid and ursolic acid in a polyherbal blend

Bulletin of the Karaganda University. "Chemistry" series Pub Date : 2022-01-01 DOI:10.31489/2022ch2/2-22-23

S. Chitlange, S. Chandani, S.P. S.P. Gandhi, P. Thorat, H. B. Lad

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Abstract

A sensitive High-performance thin-layer chromatography method was developed for simultaneous estimation of berberine, gallic acid and ursolic acid in a polyherbal blend and validated as per ICH guidelines.Polyherbal blend was prepared using widely recommended herbal plants for platelet augmentation activity viz. Carica papaya, Berberis aristata, Ocimum Sanctum and Tinospora Cordifolia. The optimized separation was obtained with TLC aluminum plates pre-coated with silica gel G60 F254 as a stationary phase and a solvent system containing Toluene : Ethyl acetate : Methanol : Formic acid (3:3:0.2:0.1 v/v/v/v). Berberine and gallic acid were found to demonstrate linearity in the range of 1μg/band – 6μg/band and ursolic acid in the range of 20 μg/band – 100 μg/band with the regression coefficient in acceptable limits. The method was also found to be specific and precise one. The accuracy of the developed method at 80 %, 100 % and 120 % levels was found to be within limits and % RSD was found to be less than 2. LOD and LOQ of all three standards were also determined. Blend was also quantified for the amount of berberine, gallic acid and ursolic acid presence and was found to be 37.8 μg, 46.1 μg and 108 μg per mg, respectively.

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hplc法同时测定复方药材中小檗碱、没食子酸和熊果酸含量的建立与验证

建立了高效薄层色谱法同时测定复方药材中小檗碱、没食子酸和熊果酸的方法，并根据ICH指南进行了验证。采用广泛推荐的具有血小板增强活性的植物——木瓜、小檗、菟丝子和堇青花制备了多药混合剂。在固定相为甲苯:乙酸乙酯:甲醇:甲酸(3:3:0.2:0.1 v/v/v/v /v)的溶剂体系下，以硅胶g60f254预包覆薄层铝板为固定相，获得了最佳的分离效果。小檗碱和没食子酸在1 ~ 6μg/波段范围内呈线性关系，熊果酸在20 ~ 100 μg/波段范围内呈线性关系，回归系数在可接受范围内。结果表明，该方法具有特异性和精确性。该方法在80%、100%和120%水平下的准确度均在限定范围内，RSD < 2。确定了三种标准的定量限和定量限。同时对混合物中小檗碱、没食子酸和熊果酸的含量进行了定量测定，分别为37.8 μg、46.1 μg和108 μg / mg。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Bulletin of the Karaganda University. "Chemistry" series

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