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  • Chem Sci Trans., 2014, 3(2),  pp 854-860  

    DOI:10.7598/cst2014.825

    Research Article

    Development and Validation of a Stability-Indicating Liquid Chromatographic Method for the Assay of Cabazitaxel

  • M. MATHRUSRI ANNAPURNA, B. VENKATESH, K. PRAMADVARA and S. HEMCHAND
  • Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam, India
    Inogent Laboratories Pvt. Ltd., Hyderabad, India
  • Abstract

    A validated stability-indicating high-performance liquid chromatographic technique was developed for the determination of cabazitaxel. Chromatographic separation was performed on Shimadzu Model CBM-20A/20 Alite, using a mixture of sodium acetate buffer (pH 4.0) and acetonitrile (30:70, v/v) as mobile phase with a flow rate of 1.0 mL/min. Cabazitaxel was subjected to stress conditions (acidic, alkaline, oxidation photolytic and thermal degradations and the method was validated as per ICH guidelines.

    Keywords

    Cabazitaxel, RP-HPLC, Stability-indicating, ICH

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