A NEW HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF SOFOSBUVIR IN TABLET DOSAGE FORM

Narottam Pal*, Tayyaba Mahtab, Sayeeda Tabasum, Sumaiyya Saleem and A. Srinivasa Rao

ABSTRACT

A simple, accurate, rapid and precise isocratic reverse phase high performance liquid chromatographic method has been developed and validated for the determination of Sofosbuvir in tablet dosage form. The chromatographic separation was carried out with a Kromosil analytical column (250×4.6mm,5μm), a mixture of 0.1% ortho phosphoric acid: acetonitrile in the ratio of 30:70 as mobile phase, at a flow rate of 1.0 ml/minute maintaining the temperature at 30ºc. UV detection was performed at 260 nm. The retention time was 2.576 for Sofosbuvir. The method was validated according to ICH guidelines and the acceptance criteria of results for accuracy, precision, linearity, robustness, limit of detection, limit of quantification and ruggedness were met in all cases. The % RSD values for Sofosbuvir in precision study was found to be 0.70%. The linearity of the calibration curve for each analyte in the desired concentration range was good (r2>0.999). The high recovery and value of low relative standard deviation confirm the suitability of the method for routine evaluation of Sofosbuvir in pharmaceutical dosage forms.

Keywords: Sofosbuvir, HPLC, Method development, validation.