Process analysis and comparison of dissolution of ambroxol hydrochloride tablets from different manufactories

Objective: To monitor the drug dissolution of ambroxol hydrochloride tablets from four manufactories and investigate the differences in quality among the tablets by using fiber optic drug dissolution test system.Methods: The paddle method with a rate of 75 r·min-1 was used.The determination and reference wavelengths were set at 244 nm and 550 nm,respectively.Dissolution data was collected every 30 seconds during 30 min run.Ambroxol hydrochloride tablets were dissolved with hydrochloride solution as the solvent(9→1 000) and were determined by 5 mm fiber optic probes.Meanwhile,the UV method in Chinese Pharmalopoeia(Chp) 2005 was used to control each other.Results: The dissolutions of ambroxol hydrochloride tablets produced by all the four manufactories met the standards of Chp 2005.There were apparent differences in dissolution speed and curves.Conclusion: The fiber-optic drug dissolution in situ test system which has an advanced monitoring function can supply more complete data and reflect the real dissolution process accurately and continuously.