Stress degradation studies on Valsartan using validated stability-indicating high-performance thin-layer chromatography

Abstract

Valsartan is a potent and specific competitive antagonist of the angiotensin-II AT 1 -receptor and is used orally for treatment of hypertension. A sensitive, selective, precise, and stability-indicating high-performance thin-layer chromatographic method for analysis of valsartan both as the bulk drug and in formulations has been developed and validated. The method uses aluminum-backed silica gel 60F 254 plates with toluene-ethyl acetate-methanol-formic acid 60.0:20.0:20.0:1.0 ( v/v ) as mobile phase. The system gave compact bands for valsartan ( R F 0.44 ± 0.05). Densitometric analysis of valsartan was performed in absorbance mode at 250 nm. Linear regression analysis data for the calibration plots revealed a good linear relationship with r 2 = 0.9946 ± 0.0013 in the working concentration range 200 to 1600 ng per band. The method was validated for precision, robustness, and recovery. The limits of detection and quantification were 25 and 150 ng per band, respectively. Valsartan was subjected to different ...