- Author:
Ling MA
1
Author Information
- Publication Type:Journal Article
- Keywords: Albendazole tablet; Consistency evaluation; Dissolution curve; Generic drug; HPLC; Similarity factor (f2)
- From: Chinese Pharmaceutical Journal 2018;53(24):2123-2126
- CountryChina
- Language:Chinese
- Abstract: OBJECTIVE: To establish a determination method of the dissolution curves of albendazole tablets with differentiation ability and investigate the similarity of dissolution curves in vitro between reference preparation and generic preparations.METHODS: Paddle method was adopted with rotation speed of 50 r•min-1 and the dissolution medium volume was 900 mL. The dissolution media were pH 1.2 hydrochloric acid solution and water. The similarity factor (f2) method was used to evaluate the comparability of dissolution curves.RESULTS: The three established dissolution curves had good distinguishing ability. As shown by the similarity factor (f2), the generic preparation from manufacture A was similar to the reference preparation, while those from the manufacture B and C were not similar.CONCLUSION: The study provides the experimental basis for the consistency evaluation of the dissolution curves of abendazole tablets.