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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 reproducible
method was developed by RP-HPLC method for estimation of related
substance and assay of cabazitaxel in Cabaxitaxel injection. A gradient
RP-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 mobile
phase B acetonitrile was used. The flow rate was adjusted to 1.3
ml/min, column oven temperature 30°C and the detection wavelength
was 230 nm with 85 minutes run time. The retention time for
cabazitaxel was found to be 13.85, 10-Dab-III impurity 2.57, Amine
impurity 3.62, Detroc oxazolidine impurity 16.17, Oxazolidine protected Cabazitaxel
impurity 22.73, Ditroc impurity 24.08, Ditroc oxazolidine impurity 59.01. Detection response
for cabazitaxel and known impurities were found linear over a range of LOQ to 250% of the
working specification limits. Proposed method was validated for specificity, accuracy,
precision, linearity, range, ruggedness & robustness. This developed method can be
applicable for routine and stability quantitative analysis.

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


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