Fiber-optic process monitoring of the dissolution of spironolactone tablets produced by different factories
Objective:To monitor the dissolution of spironolactone tablets produced by 6 factories and evaluate the quality of the tablets.Methods:The dissolution of the tablets was monitored by fiber-optic dissolution test system.Each spironolactone tablet was dissolved at 37 ℃ in 1 000 ml of 0.1 mol/L hydrochloric acid solution containing 0.1% sodium lauryl sulfate.The detection wavelength was set at 242 nm while the reference wavelength was 550 nm.Paddle method was used at the rotation rate of 75 r/min and the dissolution was monitored with 3 mm fiber-optic probe. Dissolution data and the relative dissolution rate-time curves were obtained and analyzed in the test.Results:The dissolution of spironolactone tablets produced by all of the 6 factories was up to the standard of Pharmacopoeia of the People's Republic of China,but differences were observed in the dissolution curves.Conclusion:The fiber-optic dissolution test system can provide real-time information and complete and accurate details during the dissolution process,so that the differences of dissolution among the same drug from different factories can be detected.An overall assessment of internal quality of drugs can be obtained by using fiber-optic dissolution test systerm.
spironolactonefiber-optic drug dissolution test systemdissolutiontablets
NETL
NSTL
万方数据
维普
