Stress testing of valsartan: Development and validation of a high performance liquid chromatography stability-indicating assay

Abstract

Stress testing studies were carried out on Valsartan (VAL) under hydrolytic (acidic, basic, and neutral), photolytic, oxidative, and thermal (in the solid state) conditions. Relevant degradation was observed when the drug was exposed to photolytic conditions, where two degradants (DP-1 and DP-2) were produced and when submitted to acid hydrolysis, which yielded one degradation product (DP-3). A high performance liquid chromatography method for the simultaneous determination of VAL and its degradation products was developed, optimized employing experimental design strategies, and validated, employing fully characterized standards of the degradation products. The results proved the stability-indicating property of the method.