Abstract

ANALYTICAL DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF RELATED SUBSTANCES AND ASSAY OF CABAZITAXEL IN CABAZITAXEL INJECTION DOSAGES FORM

Alok K Singh*, Dr. Amrish Chandra, Dr. Girendra K Gautam

Abstract

A simple, accurate, precise, rugged, robust, linear and reproduciblemethod was developed by RP-HPLC method for estimation of relatedsubstance and assay of cabazitaxel in Cabaxitaxel injection. A gradientRP-HPLC method was developed and validated on C-18 Column(Sunfire, 150 x 4.6 mm, 3.5 μm) using 0.05 M KH2P04 and 0.2% of 1-octane sulphonic acid with pH 2.0 as mobile phase A, while for mobilephase B acetonitrile was used. The flow rate was adjusted to 1.3ml/min, column oven temperature 30°C and the detection wavelengthwas 230 nm with 85 minutes run time. The retention time forcabazitaxel was found to be 13.85, 10-Dab-III impurity 2.57, Amineimpurity 3.62, Detroc oxazolidine impurity 16.17, Oxazolidine protected Cabazitaxelimpurity 22.73, Ditroc impurity 24.08, Ditroc oxazolidine impurity 59.01. Detection responsefor cabazitaxel and known impurities were found linear over a range of LOQ to 250% of theworking specification limits. Proposed method was validated for specificity, accuracy,precision, linearity, range, ruggedness & robustness. This developed method can beapplicable for routine and stability quantitative analysis.

Keywords: Cabaxitaxel, Impurities, RP- HPLC, Stability indicating, Method Development and Validation.