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

BIANHINI, R. M.; CASTELLANO, P. M.; KAUFMAN, T. S.

JOURNAL OF LIQUID CHROMATOGRAPHY AND RELATED TECHNOLOGIES

TAYLOR & FRANCIS INC

Lugar: Nueva York; Año: 2011 vol. 35 p. 1053 - 1069

1082-6076

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 stabilityindicating property of the method.