Stability indicating RP-HPLC method development and validation for the simultaneous determination of Sofosbuvir and Velpatasvir in tablet dosage forms

Jahnavi Bandla, S. Ganapaty


Stability indicating RP-HPLC method was developed for the simultaneous quantitation of
Sofosbuvir and Velpatasvir in its pharmaceutical dosage form and validated. The drugs were
separated on Discovery C18 (150mm x 4.6mm, 5µ) column using 0.01N potassium
dihydrogen phosphate buffer and acetonitrile (50:50%v/v) as mobile phase on isocratic mode.
The mobile phase is pump into the column at flow rate of 1.0ml/min and column oven
temperature is maintained at 30ºC. The drugs were detected at a wavelength 240nm. The
retention time for Sofosbuvir and Velpatasvir were found to be 2.32min and 3.34min
respectively. The developed method is validated in accordance with ICH guidelines. The
method was found to be accurate, precise, specific and robust. The method obeys Beer’s law
at a concentration range of 100µg/ml – 600µg/ml of Sofosbuvir and 25µg/ml – 150µg/ml of
Velpatasvir, with correlation coefficient of 0.999 for both the drugs. The drugs were found to
be stable and less prone to degradation when they are subjected to various stress conditions


Sofosbuvir, Velpatasvir, RP-HPLC, Stability indicating, Method development, Validation.

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