Comparative dissolution study in different pH conditions of Bilastine Tablet

The rate of drug release of a solid dosage form through different periods can be assessed using disintegration studies. In this study, we aimed to compare 2 bilastine tablets available in Bangladeshi market. Three different buffer media are utilised, having pH 1.2, 4.5 and 6.8, respectively. The HPLC parameters are as follows: mobile phase, buffer: acetonitrile (pH 4.0), 6.5:3.5; column, Kromasil C18 (150 mm X 4.6 mm, and 5μm); detection at a wavelength of 207 nm with the temperature set at an oven temperature of 25°C and the flow rate was kept at 1 mL/min using PDA detector. The similarity factor of the type a bilastine tablets (at pH 1.2) is 83.27, and for type B bilastine tablets (at pH 1.2), the difference factor is 1.01. Both of these requirements are fulfilled by the USP standard. But in other conditions, pH 4.6 and 6.8 are not the same. These results show that the dissolution profile of the B category tablet is not suitable formulation further in vivo test is required to justify the plasma profile level at different time intervals.