1GITAM Institute of Science, GITAM (Deemed to be University), Visakhapatnam, India
2GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India
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.
Docetaxel, RP-HPLC, Related substances, Gradient mode, Impurities, Stability indicating