Development and validation of valganciclovir hydrochloride in bulk and pharmaceutical dosage form by HPTLC method

International Journal of Advanced Chemistry Pub Date : 2020-09-19 DOI:10.14419/ijac.v8i2.30926

K. K, J. Gnana Babu C., Sowmya H.G

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引用次数: 1

Abstract

A simple, rapid and accurate High performance thin layer chromatography is described for the Development and validation of HPTLC method for Valganciclovir Hydrochloride in bulk and Pharmaceutical dosage form. The separation is carried out on Merck TLC aluminum sheets of silica gel 60 F254 using Chloroform: Methanol: Ammonia (6.5:3.4:0.1v/v) mobile phase. Quantification was done by Densitometric scanning at 254nm. The linearity was found to be the range of 100-500ng/spot for Valganciclovir hydrochloride with the correlation coefficient of 0.9993. The regression equation was found to be Y=10.168x-94.8. The Rf value of Valganciclovir hydrochloride was found to be 0.74. The LOD and LOQ were found to 9.19 and 27.87 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 Valganciclovir hydrochloride in bulk and Pharmaceutical dosage form.

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高效液相色谱法研究盐酸缬更昔洛韦原料药和药剂剂的研制与验证

建立了一种简便、快速、准确的高效薄层色谱法，并对盐酸缬更昔洛韦原料药和制剂的hplc法进行了验证。采用三氯甲烷:甲醇:氨(6.5:3.4:0.1v/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。盐酸缬更昔洛韦在100 ~ 500ng/点范围内呈线性关系，相关系数为0.9993。回归方程为Y=10.168x-94.8。盐酸缬更昔洛韦的Rf值为0.74。LOD和LOQ分别为9.19和27.87。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，适用于原料药和制剂剂型盐酸缬更昔洛韦的分析。

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International Journal of Advanced Chemistry

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