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Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 7
First page : ( 3007) Last page : ( 3012)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.00554.1

Stability Indicating RP-HPLC method for the determination of Abiraterone (An Anti-Cancer Drug)

Annapurna Mukthinuthalapati Mathrusri*, Pradhan Debi Prasad, Routhu Krishna Chaitanya

Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra pradesh-530045, India

*Corresponding Author E-mail: mannapurna.mukthinuthalapati@gitam.edu

Online published on 31 October, 2018.

Abstract

Abiraterone is used for the treatment of prostate cancer for men. Abiraterone is available as Abiraterone acetate. Food and drug administration approves Abiraterone for treatment of men with advanced prostate cancer. A new stability indicating RP-HPLC method has been proposed for the quantification of Abiraterone. Capcell PAK C18 column (100 mm × 4.6 mm i.d., 3 μm particle size) was used for the chromatographic study of Abiraterone acetate with mobile phase mixture 0.1% acetic acid and acetonitrile (11:89 v/v) (Flow rate: 1.2 mL/min) on Shimadzu Model CBM-20A/20 Alite HPLC system (PDA detector). Forced degradation studies were performed and the method was validated.

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Keywords

Abiraterone, stability indicating, RP-HPLC; validation, ICH guidelines.

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