Abstract

FORCED DEGRADATION OF TENOFOVIR ALAFENAMIDE AND EMTRICITABINE: DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD

Murugan S.* and Vetrichelvan T.

ABSTRACT

In the present work, a new validated stability indicating HPLC method for quantitative determination of Tenofovir alafenamide and Emtricitabine in tablet formulation was developed. The column was Phenomenex Luna C18 column (150 mm × 4.6 mm id; 5μm particle size) and the mobile phase was composed of Methanol:Water in 0.1% of acetic acid (65:35,v/v) with a flow rate 1 ml/min. Eluents were monitored by UV detector at 260 nm. Calibration curve was linear in the concentration ranges 5 – 25 μg/ml (R2 value is 0.9996) for Tenofovir alafenamide and 40 – 200μg/ml (R2 value is 0.9998) for Emtricitabine. Tenofovir alafenamide and Emtricitabine were subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. The developed method was found to give good separation between pure drug and degraded products. The proposed method was successfully applied for the stability assay of Tenofovir alafenamide and Emtricitabine in tablet formulation and validated as per ICH guidelines.

Keywords: Tenofovir alafenamide, Emtricitabine, HPLC Method, Forced degradation studies.