ABSTRACT:
Cabazitaxel is used in the treatment of hormone-refractory prostate cancer. It is a semisynthetic taxane that can be used as a precursor molecule obtained from yew tree needles. The authors have developed a stability indicating liquid chromatographic method for the determination of Cabazitaxel in pharmaceutical products. Shimadzu Model CBM-20A/20 Alite HPLC system (PDA detector) with Zorbax SB C18 column (150 mm × 4.6 mm i.d., 3.5 µm particle size) was selected for the quantification of Cabazitaxel. A mixture of tetra butyl ammonium hydrogen sulphate and methanol was used as the mobile phase with a flow rate of 1.0 mL/min (UV detection at 210 nm). The proposed analytical method was statistically validated and forced degradation studies were conducted. Cabazitaxel has shown linearity over the concentration range 0.1-200 µg/mL with regression equation y = 26145x + 22943 (r2=0.9997) and considerable degradation was observed in acidic, alkaline and oxidation conditions. The method is specific as the resolution of Cabazitaxelwas good in presence of its degradation products. This validated stability indicating liquid chromatographic method can be used for the determination of Cabazitaxel in biological studies as well as for the pharmaceutical products.