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  • Chem Sci Trans., 2014, 3(3),  pp 961-968  

    DOI:10.7598/cst2014.843

    Research Article

    A Validated Stability-Indicating Liquid Chromatographic Method for the Determination of Exemestane

  • M. MATHRUSRI ANNAPURNA**, B. SWATI, D. NAGA RAMYA, K. PRAMADVARA, A. SRI RAM and N. ASLESHA
  • Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam, India
  • Abstract

    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.

    Keywords

    Exemestane, Liquid chromatography, Validation, Stability-indicating, ICH

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