1Department of Chemistry, Faculty of Science, Kafr El-Sheikh University, Kafr El-Sheikh, Egypt
2Zeta Pharma for Pharmaceutical Industries, Sadat City, Menoufia Governorate, Egypt
3Electrochemistry Laboratory Chemistry Department Faculty of Science, Menoufia University, Egypt
*Corresponding Author E-mail: wafaa.ahmed1992@gmail.com
Online published on 8 June, 2021.
A new, simple, accurate, and specific RP-HPLC stability method for determining bilastine was developed and validated. The proposed method was administered using C18 BDS Hypersil thermo column (4.6 × 250mm i.d), 5 μm particle size with a combination of potassium dihydrogen phosphate buffer pH 6.0: acetonitrile: methanol (50:25:25) as the mobile phase at a wavelength of 220nm. The retention time was 3.9 min for bilastine. The calibration plot was linear over the concentration range of 14.4-33.6μg/ml bilastine with LOD and LOQ of 0.04 and 0.11μg/ml, respectively. The technique was validated for linearity, sensitivity, accuracy, precision, and robustness. Percent recoveries were observed to be nearly 100%. The validated method was used for determining bilastine in Pharmabilast(R) tablets. The technique could be appropriate for routine evaluation at laboratories.
Bilastine, Analytical method development, RP-HPLC, Anti allergenic agent, Pharmabilast(R)
