Vol. 8, Issue 3 (2019)

Author(s):
Deniz Çıkla Yılmaz, Bilge Bebek and Serap Karaderi

Abstract:
In the present work, a new validated stability indicating HPLC method for quantitative determination of valsartan in tablet formulation was developed. The column was Inertsil ODS-3 (4.0 x 125 mm id; 5µm particle size) and the mobile phase was composed of 50 mM NaH₂PO₄ (pH 2,6) - methanol (35:65, v/v) with a flow rate 1 ml/min. Eluents were monitored by DAD detector at 254 nm. Calibration curve was linear in the concentration range 2,4 – 60 µg/ml (R²>0.999). Valsartan was 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 product. The proposed method was successfully applied for the stability assay of valsartan in tablet formulation and validated as per ICH guidelines.