Abstract:
OBJECTIVE To establish a dissolution method for gefitinib tablets. METHODS Paddle apparatus was used. The drug concentrations in samples were determined by HPLC. The dissolution media, rotational speed and time were investigated to establish the dissolution method. And dissolution test of different preparations were carried out by the established method. RESULTS The dissolution method was as follows: paddle apparatus, the rotational speed of 50 r·min
-1, and the dissolution time of 60 min. pH 1.0 hydrochloric acid solution, pH 4.5 acetate buffer solution, 5% Polysorbate 80 solution and pH 6.8 phosphate buffer solution containing 5% Polysorbate 80 were as dissolution media. Dissolution media, excipients and membrane adsorption did not interferer the determination of gefitinib in samples by HPLC. It showed good linearity in drug concentration from 10 μg·mL
-1 to 300 μg·mL
-1. The recoveries ranged from 98% to 100%. The RSD of precision and stability were less than 2%. CONCLUSION The dissolution method is discriminative, which is suitable as a standard method for the formulation study of gefitinib tablets.