1GITAM Institute of Science, GITAM (Deemed to be University), Visakhapatnam, India
2GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India
*Corresponding Author E-mail: Hemchand.suryadevara@gmail.com
Online published on 24 December, 2019.
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
