Authors : Alok K Singh, Dr. Amrish Chandra, Dr. Girendra K Gautam
DOI : 10.20959/wjpr20184-10554
Volume : 7
Issue : 4
Year : 2016
Page No : 535-59
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.