Development and Validation of a Stability-Indicating HPLC Method for the Determination of the Impurities in Cabazitaxel

A novel stability-indicating high-performance liquid chromatographic (HPLC) method has been developed and validated for the analysis of the impurities A–G in cabazitaxel. Chromatographic separation was achieved on a Welch Xtimate™ C18 (250 × 4.6 mm; 5 μm) column, using the mixture of 0.02 mol L−1 sodium dihydrogen phosphate buffer pH 3.0 (pH value was adjusted with phosphoric acid) and acetonitrile as mobile phase by gradient elution with a flow rate of 1.0 mL min−1, and UV detection was performed at 230 nm. The column temperature was maintained at 40 °C by column oven. The method was validated according to the International Conference on Harmonization (ICH) guidelines. Linearity (r > 0.9990) was observed over the concentration ranges of 25.0–1500.0, 31.5–1518.0, 74.9–1796.8, 65.6–1573.2, 59.4–1425.6, 22.2–1332.0, 1.3–1570.8, 30.8–1476.0 ng mL−1 of cabazitaxel and its impurities A–G, respectively. The RSD value of the recovery for each impurity was <5.0 % (n = 9). The method was found simple and rapid with good specificity and robustness, which can be suitable for the determination of the impurities in cabazitaxel.