Development and validation of a new stability indicating ultrafast liquid chromatographic method for the determination of Exemestane tablets

Abstract

Exemestane is an irreversible steroidal aromatase inactivator. Exemestane is used for postmenopausal women who are suffering with estrogen receptor positive early breast cancer as an adjuvant treatment. A new stability indicating ultrafast liquid chromatographic method was developed and validated for the determination of Exemestane. Shimadzu Model UFLC system with PDA detector was used for the present study. Mobile phase consisting of tetra butyl ammonium hydrogen sulphate and acetonitrile (30: 70, v/v) was used with a flow rate of 1.2 mL/min (Detection wavelength 250 nm). Exemestane shows linearity 0.5–100 µg/mL with linear regression equation y = 62584 x + 599.1 (R2 = 0.9999). The LOD and LOQ were found to be 0.1401 and 0.4348 µg/mL. Stress degradation studies were performed and method was validated as per ICH guidelines.