A stability indicating liquid chromatographic method was developed for the determination of Exemestane in presence of degradation products using Zorbax SB C18 (150 mm × 4.6 mm i. d., 3.5 μm particle size) column with a flow rate 1.2 mL/min (UV detection 247 nm). Linearity was observed over a concentration range 0.1-200 μg/mL with regression equation y = 56288 x - 3004 (R2 = 0.999). Forced degradation studies were performed and Exemestane is reported to be highly sensitive towards oxidation. The method was validated as per ICH guidelines.
Exemestane, Liquid chromatography, Validation, Stability-indicating, ICH