Study on Consistency Evaluation of the Dissolution of Generic and Original Preparations of Clozapine Tablet

OBJECTIVE To establish a new method for the dissolution curve determination of clozapine tablet, and evaluate the comparability of dissolution curve of 9 domestic generic tablets and the original tablet. METHODS With the dissolutive medium of hydrochloric acid solution (pH 1.0), acetate buffer (pH 4.0), phosphate buffer (pH 6.8) and water (0.2% SDS), the dissolution behaviors of generic and original preparations of clozapine were detected, and the dissolution curves of consistency were evaluated by calculating the similarity factor(f₂). RESULTS The two domestic pharmaceutical company products were all in line with the original tablet in the dissolution curve similarities of four media, compared to the other samples showing difference from original preparation. CONCLUSION The new dissolution method is suitable for dissolution curve determination of clozapine tablet, making reference for further quality consistency evaluation.