High Performance liquid chromatographic Method for the Determination of Sofosbuvir in pharmaceutical dosage forms

Sofosbuvir (brandnames Sovaldi, Hepcinat, Resof, Hep cvir, and SoviHep) is a nucleotide analog used in combination with other drugs for the treatment of hepatitis C virus (HCV) infection. Sovaldi® 40 mg Film-coated tablet are manufactured by Gilead Sciences. They are used for oral administration and available in 40 mg, 30 mg, or 20 mg of Sofosbuvir (equivalent to 59.12 mg, 44.34 mg, or 29.56 mg Sofosbuvirdimaleate, respectively) [2]. There are no analytical methods that have been reported for the estimation of Sofosbuvir in bulk and in pharmaceutical formulations [3-15]. The present HPLC method deals with new simple, accurate and reliable estimation of Sofosbuvir in sterile pharmaceutical tablets. The other methods reported mainly on the determination of Sofosbuvir in plasma, blood samples and biological fluids including tissue homogenates. Such methods may not be suitable for regular/routine analysis for Sofosbuvir in pharmaceutical industry because of diversity and complexity in sample matrix.