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