New Validated Stability-Indicating RP-HPLC Method for The Determination of Docetaxel and Its Related Substances

Docetaxel is used for the treatment of castration resistant prostate cancer. Docetaxel is a semi synthetic chemo therapeutic agent extracted from the leaves of Taxus baccata. Two process related substances and four impurities were separated and quantified using Sunfire C18 column (250 x 4.6 mm, 5µm particle size) on gradient mode (40 ± 5°C). A mixture of acetonitrile: 0.01 % Acetic acid was used as mobile phase and a mixture of acetonitrile: methanol (1:1, v/v) was used as diluent and the compounds were monitored at 230 nm. Forced degradation studies were performed and the method was validated as per ICH guidelines.