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Research Journal of Pharmacy and Technology
Year : 2019, Volume : 12, Issue : 9
First page : ( 4165) Last page : ( 4181)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2019.00719.4

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

Hemchand S.1,*, Babu R. Ravi Chandra1, Annapurna Mukthinuthalapati Mathrusri2

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.

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Keywords

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

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