DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF SOFOSBUVIR IN ITS SYNTHETIC MIXTURE

Sandesh R. Lodha*, Hema G. Kamalja, Rimpal R. Patel, Shailesh A. Shah, Pintu B Prajapati, Gajanan G. Kalyankar

ABSTRACT

A stability indicating HPTLC method was developed and validated for estimation of Sofosbuvir in its synthetic mixture. Chromatographic separation was performed on pre-coated silica gel 60F254 aluminum plates using the mobile phase Toluene: Acetone: Acetic Acid: Water (6.5:3.5:1:0.2v/v). The Rf value for Sofosbuvir was found to be 0.67. The spots were scanned densitometrically at 267 nm. The solvent system was able to separate Sofosbuvir and its degradation products formed under acidic, alkaline and oxidative condition. Developed HPTLC method was validated as per ICH Q2 (R1) guideline. The linear regression analysis data for the calibration plots showed a good linear relationship with R2 value of Sofosbuvir is 0.997 in the concentration range of 200-1000 ng/band for Sofosbuvir. Percent recovery of drug was found in the range of 98.40-101.76 % by developed method. Limit of detection and limit of quantitation was found to be 16.08 ng/band and 48.73 ng/band for Sofosbuvir respectively. The method was applied to estimate Sofosbuvir in its Synthetic mixture.

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