Evaluation of in vitro dissolution behavior of 13 domestic ibuprofen tablets using disodium hydrogen phosphate citrate buffer solution (pH=5.5) as dissolution medium
Wang Wan1, Li Yuxin 1, Zheng Jinfeng 1, Lan Wen 1, Tan Ying 1, Luo Shi 2, Wen Qin 1, Chen Hongyu 1
1. Hunan Institute for Drug Control, Changsha 410001, China; 2. Hunan Drug Inspection Center, Changsha 410001, China
The in vitro dissolution behavior of 13 domestic ibuprofen tablets was evaluated by using disodium hydrogen phosphate citric acid buffer solution (pH=5.5) as the dissolution medium according to the quality standard of evaluated enterprise A. HPLC detection method was adopted. The chromatographic column is Kromasil 100-5-C18 (150×4.6 mm, 5 μm), The mobile phase is chloroacetic acid solution (pH=3.0) - acetonitrile (40∶60). Detection wavelength is 263 nm, Injection volume 20 μL. Cumulative dissolution experiments on 13 domestic ibuprofen enterprises was conducted. The factors were compared similarity. The results indicate that among the 13 companies, only the E and K f2 factors of the evaluated companies are greater than 50, while the other 11 companies are all less than 50, 11 companies may have differences in efficacy, and consistency evaluation should be conducted as soon as possible.
