Abstract

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.

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