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

1082-6076

Peer Review Only2AbstractStress testing studies were carried out on Valsartan (VAL) under hydrolytic (acidic,basic and neutral), photolytic, oxidative and thermal (in the solid state) conditions. Relevantdegradation was observed when the drug was exposed to photolytic conditions, where twodegradants (DP-1 and DP-2) were produced and when submitted to acid hydrolysis, whichyielded one degradation product (DP-3). A high performance liquid chromatography methodfor the simultaneous determination of VAL and its degradation products was developed,optimized employing experimental design strategies and validated, employing fullycharacterized standards of the degradation products. The results proved the stabilityindicating property of the method.