Dissolution process analysis and comparison of valsartan capsules from different producers by fiber-chemical sensor

Objective:To investigate the dissolution curves and compare internal quality of Valsartan capsules from different manufacturers so as to make a reference for drug quality control and clinical medication.Method:The dissolution process of Valsartan capsules was monitored in the following 4 mediums:pH 6.8,pH 4.5,pH 1.2 and water by fiber-optic dissolution test system.The dissolution curve was evaluated by f2 similar factor.Results:The dissolution rate of Valsartan capsules from 4 manufacturers exceeded 80% in 30 min and accorded with the Chinese Pharmacopoeia(ChP) in pH 6.8 buffer solution,but dissolution curve was respective various in each medium.The result indicated that it was significant difference among the quality of Valsartan capsules.Conclusion:The dissolution curve using fiber-optic dissolution tester process analysis to monitor the dissolution of solid preparation that is straighter to reflect preparation technology,uniformity and drug quality than one-point dissolution.It is necessary to inspect the dissolution of oral solid preparation from different manufacturers in the different mediums.