Study on stress degradation behaviour of abiraterone acetate in film coated tablets and identification of major stress degradation product by liquid chromatography-ultraviolet-electrospray ionization- mass spectrometry
By: Bukkapatnam, V
.
Contributor(s): Mukthinuthalapati, Mathrusri Annapurna.
Publisher: Mumbai Indian Journal of Pharmaceutical Science 2022Edition: Vol.84(2), Mar-Apr.Description: 300-310p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical sciencesSummary: Abiraterone acetate is an androgen biosynthesis inhibitor used in the treatment of prostate cancer. This
study focuses on a simple, economical and systematic liquid-chromatographic and mass spectroscopic
method to study the stress degradation behavior of abiraterone acetate under various stress conditions
along with its validation. The chromatographic separation of abiraterone acetate and its major degradation
product is achieved on Capcell PAK C 18 MG-III (100×4.6 mm, 3 μm) column using combination of 0.1 %
acetic acid and acetonitrile as mobile phase with a flow rate of 1.2 ml/min and the wavelength of detection
is selected as 251 nm. The drug was degraded extensively in acidic and basic hydrolysis. A tentative
degradation pathway of drug in acidic and alkaline condition was predicted. The developed analytical
method was found selective, accurate, precise and robust in accordance with International Conference on
Harmonisation guidelines. The method will also suffice the suitability for the assay of abiraterone acetate
in bulk and finished products.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
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School of Pharmacy Archieval Section | Not for loan | 2022-2171 |
Abiraterone acetate is an androgen biosynthesis inhibitor used in the treatment of prostate cancer. This
study focuses on a simple, economical and systematic liquid-chromatographic and mass spectroscopic
method to study the stress degradation behavior of abiraterone acetate under various stress conditions
along with its validation. The chromatographic separation of abiraterone acetate and its major degradation
product is achieved on Capcell PAK C 18 MG-III (100×4.6 mm, 3 μm) column using combination of 0.1 %
acetic acid and acetonitrile as mobile phase with a flow rate of 1.2 ml/min and the wavelength of detection
is selected as 251 nm. The drug was degraded extensively in acidic and basic hydrolysis. A tentative
degradation pathway of drug in acidic and alkaline condition was predicted. The developed analytical
method was found selective, accurate, precise and robust in accordance with International Conference on
Harmonisation guidelines. The method will also suffice the suitability for the assay of abiraterone acetate
in bulk and finished products.
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