Development and validation of UV spectroscopic method for the estimation of sofosbuvir in bulk and pharmaceutical dosage form
Jagruthi N., Shalem K., Sri Vijaya*, Madhuri M. A.
Department of Pharmaceutical Analysis, Malla Reddy College of Pharmacy, (Affiliated to Osmania University), Maisammaguda, Secunderabad-500 014
*Corresponding Author E-mail:
Online published on 21 August, 2018.
The main objective was to develop and validate the UV-spectrophotometric method for the estimation of sofosbuvir in bulk and pharmaceutical formulations as per ICH guidelines. A simple, sensitive and accurate UV-spectrophotometric method has been developed using acetonitrile: water (45: 55 v/v)a solvent for the estimation of sofosbuvir from bulk and pharmaceutical formulation. The λmax of sofosbuvir was found to be 260 nm it was proved linearity in the concentration range 4–24 μg/ml with a correlation coefficient value of 0.999. The % recovery was found to be in the range of 99.6–101.2%. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.495 and 1.502 μg/ml, respectively. The % RSD low values are indicates the accuracy and precise of the method. The above method was a rapid tool for routine analysis of sofosbuvir the bulk and in the pharmaceutical dosage form.
Sofosbuvir, ICH, Method development, UV-spectrophotometric and pharmaceutical formulation.