Studies on dissolution rate of amiodarone hydrochloride tablets by six channel fiber-optic sensor system
Jian Chen, Jide Wang, Focs Biological
Abstract
Jian Chen, Jide Wang, Focs Biological
Abstract
Objective:To study a method which can monitor the dissolution rate of amiodarone hydrochloride tablets using six channel fiber-optic dissolution test (FODT) system and compare with that of ChP (2000). Method:The six common ends of the optic fibers were placed into dissolution vessels filled with dissolution medium of 0.25% SLS solution and put one tablet into every vessel,paddle method used at the rate of 100 r·min~(-1) and de- tector was set at 305 nm against reference wavelength of 550 nm.The dissolution process was monitored through computer.Results:The standard curve of amiodarone was linear with the concentration in the range of 20.00- 200.00 mg·L~(-1) (r=0.9999) at 305 nm using probe of 6 mm optical path.The parameters obtained by FODT had no significant difference compared with those by the method in ChP 2000 (P 0.05).Conclusion:The method ac- complished automatic determining dissolution of six tablets simultaneously and relative parameters can be directly obtained from the dissolution curves;the process is in-situ,real time,continuous and can reflect quick dissolution characters of tablets,so the dissolution information is more complete and accurate and the system succeeded in auto- mation and intelligentifieation of invitro dissolution test by the aid of the corresponding software.
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Objective:To study a method which can monitor the dissolution rate of amiodarone hydrochloride tablets using six channel fiber-optic dissolution test (FODT) system and compare with that of ChP (2000). Method:The six common ends of the optic fibers were placed into dissolution vessels filled with dissolution medium of 0.25% SLS solution and put one tablet into every vessel,paddle method used at the rate of 100 r·min~(-1) and de- tector was set at 305 nm against reference wavelength of 550 nm.The dissolution process was monitored through computer.Results:The standard curve of amiodarone was linear with the concentration in the range of 20.00- 200.00 mg·L~(-1) (r=0.9999) at 305 nm using probe of 6 mm optical path.The parameters obtained by FODT had no significant difference compared with those by the method in ChP 2000 (P 0.05).Conclusion:The method ac- complished automatic determining dissolution of six tablets simultaneously and relative parameters can be directly obtained from the dissolution curves;the process is in-situ,real time,continuous and can reflect quick dissolution characters of tablets,so the dissolution information is more complete and accurate and the system succeeded in auto- mation and intelligentifieation of invitro dissolution test by the aid of the corresponding software.
Key concepts: Dissolution, Dissolution testing, Chemistry, Chromatography, Dosage form, Analytical Chemistry (journal), Biopharmaceutics Classification System, Physical chemistry