Stability indicating hplc method for antihistamine drug ebastine along with degradation kinetic study

Author: 
Shital Patel and T. Y. Pasha

A sensitive, precise, accurate and stability indicating HPLC method was developed and validated for analysis of ebastine. The separation of ebastine from its degradation product was achieved on a C18 column using acetonitrile: 0.5% phosphoric acid (68:32 %v/v) as a mobile phase and detection was performed at 254 nm. The degradation of ebastine was studied under different ICH recommended stress conditions. The method was linear over the range of 5-120 µg/ml with correlation co-efficient of 0.9993. Limit of Detection and Limit of Quantitation, calculated mathematically, were 0.30 µg/ml and 0.91µg/ml, respectively. Ebastine was found to degrade under acid and oxidation conditions with first order reaction and zero order reaction, respectively. Half time at room temperature in acidic and oxidative condition was calculated as 11,403.67 min. and 503.32 min., respectively. The Arrhenius plot was constructed and activation energy of degradation was calculated for both conditions.

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DOI: 
http://dx.doi.org/10.24327/ijcar.2018.9376.1547
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