Determination of Related Substances in Cabazitaxel Using Reverse Phase-liquid Chromatography Method

The present paper describes the reverse phasehigh performance liquid chromatographic method and was validated as per ICH guidelines for the determination of related substances in Cabazitaxel. RP-Liquid chromatography technique was performed with pH 3.0 phosphate buffer and acetonitrile as mobile phase at a flow rate of 0.8 mL/min. on Waters 2489 UV 2695 pump, Waters 2998 PDA 2695 pump Software Empower2 photodiode array detector using Zorbax SB C18 column with UV detection at 220 nm. Linearity was observed in the concentration range of Cabazitaxel LOQ–0.10% (R2 = 0.9998), the concentration range of CBZM01 impurity 0.03–0.225% (R2 = 0.9997), the concentration range of CBZM02 impurity 0.03–0.225% (R2 = 0.9997), the concentration range of CBZN09 impurity 0.03–0.225% (R2 = 0.9998). Limit of detection (%) and the limit of quantitation (ng/mL) were found to be CBZM01 impurity 0.002% and 73ng/mL, CBZM02 impurity 0.002 % and 71ng/mL, CBZN09 impurity 0.002 % and 6ng/mL and Cabazitaxel 0.002 % and 0.008 % respectively. The percent recovery was in good agreement with the labeled amount in the dosage forms and hence, the method is specific, simple, reproducible and accurate for the determination of Cabazitaxel.