生物学的同等性とバイオアベイラビリティのジャーナル

概要

A Validated Stability-indicating Liquid Chromatographic Method for Determination of Cabazitaxel-A Novel Microtubule Inhibitor

Mathrusri Annapurna Mukthinuthalapati, Venkatesh Bukkapatnam and Naga Supriya Grandhi

Cabazitaxel is used to treat advanced prostate cancer. Cabazitaxel is a semi-synthetic derivative of the natural taxoid 10-deacetylbaccatin III with potential antineoplastic activity. Cabazitaxel is also known as XRP6258, a semisynthetic taxane from a single diastereoisomer of 10-deacetyl baccatin III derived from the needles of various Taxus species. A stability-indicating high performance liquid chromatographic technique was developed for the determination of Cabazitaxel in bulk and pharmaceutical formulations. Chromatographic separation was performed on Shimadzu Model CBM-20A/20 Alite, using Zorbax SB-C18 column (150 mm×4.6 mm i.d., 3.5 μm particle size) with a mixture of 0.1% ortho phosphoric acid and methanol (20:80, v/v) as mobile phase with a flow rate of 1.0 ml/ min. Cabazitaxel was subjected to stress conditions (acidic, alkaline, oxidation photolytic and thermal degradations and the method were validated as per ICH guidelines.