Research Journal of Pharmacy and Technology

SCOPUS
  • Year: 2019
  • Volume: 12
  • Issue: 9

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

  • Author:
  • S. Hemchand1,, R. Ravi Chandra Babu1, Mukthinuthalapati Mathrusri Annapurna2
  • Total Page Count: 17
  • Page Number: 4165 to 4181

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.

Abstract

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.

Keywords

Docetaxel, RP-HPLC, Related substances, Gradient mode, Impurities, Stability indicating