Abstract:
OBJECTIVE To study the similarity of the dissolution curves between original and generic simvastatin tablets, and establish a distinguishable dissolution method.
METHODS The experimental condition of dissolution methods in Japanese orange book and Chinese Pharmacopoeia were adopted. With the original drug in parallel, the dissolution curves of generic tablets were compared by the similarity factor method. Meanwhile, the new discriminative dissolution method was developed as follows:paddle stirring at 50 r·min
-1, pH 7.0 phosphate buffer solution (900 mL) containing 0.4% SDS as dissolution medium, HPLC analysis after 30 min, and the limit was set at 80%.
RESULTS The experimental conditions following the Japanese orange book and Chinese Pharmacopoeia could not discriminate the original and generic tablets. The newly established method could afford a significant difference at 30 min.
CONCLUSION The concentration of SDS in the dissolution medium is found to be essential, and even the key to discriminate the dissolution behavior of simvastatin tablets. This result provides the experimental basis for consistency evaluation.