厄贝沙坦片剂和散装剂型hplc法的建立与验证

Yogeesh C S, S. H G, J. Gnana Babu C.
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摘要

建立了一种简便、快速、准确的高效薄层色谱法,用于厄贝沙坦散装和药用剂型的hplc分析。采用醋酸乙酯:氯仿(6.5:3.5v/v)流动相,在默克薄层色谱法硅胶60f254铝板上进行分离。定量采用254nm密度扫描。厄贝沙坦在100 ~ 500ng/spot范围内呈线性关系,相关系数为0.9992。回归方程为Y=7.2733x+703.15。厄贝沙坦的Rf值为0.55。LOD和LOQ分别为8.24和24.74。平均回收率为99.66%,表明该方法不受制剂中辅料的干扰。同时,相对标准偏差在2%的范围内。上述方法根据ICH指南进行了验证。所建立的方法准确、精密度高,适用于厄贝沙坦原料药和制剂剂型的分析。
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Development and validatation of HPTLC method for estimation of irbesartan in bulk and tablet dosage form
A simple, rapid and accurate High performance thin layer chromatography is described for the Development and validation of HPTLC method for Irbesartan in bulk and Pharmaceutical dosage form. The separation is carried out on Merck TLC aluminum sheets of silica gel 60 F254 using Ethyl acetate: Chloroform (6.5:3.5v/v) mobile phase. Quantification was done by Densitometric scanning at 254nm. The linearity was found to be the range of 100-500ng/spot for Irbesartan with the correlation coefficient of 0.9992. The regression equation was found to be Y=7.2733x+703.15. The Rf value of Irbesartan was found to be 0.55. The LOD and LOQ were found to 8.24 and 24.74 respectively. Average recovery was found to be 99.66% which show that the method was free from interference from excipients present in the formulation. Simultaneously the Percentage relative standard deviation was well within the range of 2%. The above method was validated according to the ICH guidelines. The established method enabled accurate, precise and applied to the analysis of Irbesartan in bulk and Pharmaceutical dosage form.  
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