Volume : 08, Issue : 08, August – 2021

Title:

09.A CONCISE REVIEW BASED ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF SOFOSBUVIR BULK AND MARKETED DOSAGE FORM

Authors :

Mrs. Hema V. Badgujar* , Twinkle S. Rana, Dr. Ashok H. Akabari, Dr. Bhumika C. Desai

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 60 F254 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 densitometric ally 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 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 98.53 – 100.34 % by developed method. Limit of detection and limit of quantitation was found to be 16.0ng/band and 48.73 ng/band for Sofosbuvir, respectively. Developed HPTLC method was validated for accuracy, linearity, precision etc. The method was applied to estimate Sofosbuvir in its Synthetic mixture
Keywords: Sofosbuvir; Analytical Profile; HPLC; HPTLC; Bioanalytical; Stability indicating

Cite This Article:

Please cite this article in press Hema V. Badgujar et al., A Concise Review Based On Analytical Method Development And Validation Of Sofosbuvir Bulk And Marketed Dosage Form.., Indo Am. J. P. Sci, 2021; 08(08).

Number of Downloads : 10

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