STABILITY INDICATING UHPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND LEDIPASVIR IN TABLET DOSAGE FORMAbstract
A stability-indicating UHPLC method was developed for the simultaneous estimation of Sofosbuvir (SOF) and Ledipasvir (LPS) in bulk and tablet dosage form. The study was performed using C18 BEH column (210 mm × 50 mm, 1.7 µm), with a mobile phase consisting of acetonitrile (55% v/v) and phosphate buffer of pH 3 (45% v/v) at a flow rate of 0.3 ml/min. The detection was carried at 247 nm using PDA detector and the retention times were found to be 0.7 and 1.2 min for SOF and LPS respectively. The developed method was validated according to ICH guidelines and the results were statistically validated. The method was found to be linear in the concentration range of 80 – 240 µg/ml for SOF with r2 value 0.999 and 18 – 54 µg/ml for LPS with r2 value 0.999. The % RSD value for precision, measured as repeatability and intermediate precision was less than 2 for both the analytes. The recovery percentages were found to be 100.13 and 99.93 for SOF and LPS respectively. The analytes were subjected to stress conditions (forced degradation studies) such as acidic, basic, peroxide, thermal, and photodegradation and the results showed that % degradation was within limits and drugs can be estimated in the presence of degradants. The method was successfully applied to the assay of Sofosbuvir and Ledipasvir in tablet dosage form. Thus, the proposed method is simple, accurate, precise and can be applied confidently for the quantitative determination of Sofosbuvir and Ledipasvir in tablets even in the presence of degradants.
D. Narla * and N. Pappula
Department of Pharmaceutical Analysis, Aditya College of Pharmacy, Surampalem, Andhra Pradesh, India.
17 April 2019
09 August 2019
06 November 2019
01 February 2020