Stability indicating normal phase hptlc method for estimation of sofosbuvir in bulk drug and pharmaceutical dosage form

Vishal. G. Gadade., Sachin L. Darkunde., Rabindra K. Nanda., Santosh S. Bhujbal and Ritesh P. Bhole

This paper presents the development and validation of normal phase High Performance Thin Layer Chromatography methods for analysis of Sofosbuvir in Bulk and tablet Dosage form. Chromatography was performed on silica gel 60F254 plate as stationary phase and the mobile phase comprised of Toluene: Methanol (7:3, v/v). Sofosbuvir showed Rf value of 0.60±0.03 was scanned at 265 nm using Camag TLC Scanner 3. Method was validated according to ICH guidelines. Determination of correlation coefficient was found to be 0.9948 in the concentration ranges 200-1200 ng/band. The method was validated for precision and recovery. The limits of detection and quantification were 95 and 200 ng/spot respectively. The developed method was successfully used for the assay of Sofosbuvir tablet formulations. The method is simple, sensitive and precise; it can be used for the routine quality control testing of marketed formulations.

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