Evaluation of in Vitro Dissolution of Dimenhydrinate Tablets by Fiber-optic Dissolution Monitor

OBJECTIVE: To monitor the in vitro dissolution of Dimenhydrinate tablets from different manufacturers by Fiber-optic dissolution monitor, and to investigate the quality of it. METHODS: Detection wavelength was set at 278 nm and calibration wavelength was 550 nm. The dissolution was monitored with 2 mm fiber optic probe at rotation speed of 50 r·min-1. Each dimenhydrinate tablet was dissolved in 900 mL of water at 37 ℃. Dissolution data were collected every 30 seconds. The paddle method was used to determine the dissolution of samples and compared with the method stated in Chinese Pharmacopeia. RESULTS: The results of dissolution monitoring showed the dissolutions of different batches of samples were qualified to the standards of Chinese Pharmacopoeia, but a significant difference was observed in their dissolution curves, i.e there was difference in dissolution process. There was no significant difference in the dissolution of same batches of samples at 45 min using monitor and the method of Chinese Pharmacopeia. But the dissolution curves of them were different from one another. CONCLUSION: Compared with the method of Chinese Pharmacopeia, the fiber-optic dissolution monitor is capable of monitoring the real dissolution process of drug and supplying more complete and accurate details of the dissolution process. It can be used to evaluate in vitro dissolution process of drug.