Stability and Degradation Kinetic study of Bilastine in Solution State by RP-HPLC Method

Aim: The current study dealt with the degradation behavior of Bilastine and kinetics a drug in solution state. Background: Very limited information on effect pH maximum stability has been published. In order to understand bilastine, aqueous studies were carried out, because such bilastine have not reported literature, further no methods about shelf-life determination bilastine. design involves selection indicating RP-HPLC method for estimation then evaluation kinetics, validation proposed method. Results: Shimadzu HPLC series 1100 was used stress analysis tablet dosage form. performed using Agilent ZORBAX SB-C8 (4.6×150×5µm) column Phosphate Buffer: Acetonitrile (pH-5.0) ratio 60:40 as mobile phase; wavelength selected 254nm flow rate 1mL/min at which showed sharp peak. isocratic pump mode injection volume 20µl. phase is diluent. found be linear over range 10 50 µg/mL. by placing standard samples 7 different buffer, oxidative neutral hydrolytic solutions oven 40ºC, 60⁰C room temperature an interval 30, 60, 90, 120, 150, 180 mints samples. results indicated that pH, temperature, ionic strength oxidation greatly influence followed pseudo-first-order kinetics. most stable neutral, alkaline, lower conditions strength. Conclusion: specific, selective robust successfully applied its assay, (stress testing) state.
 Keywords: Degradation, Stability, Bilastine, RP-HPLC, Kinetics