Studies On The Quality Control Of Acarbose Tablet

Acarbose is a pseudo-tetrasaccharide synthesized from living organisms. Through inhibition on α-glucosidase in small intestine, Acarbose could suppress polysaccharides decomposition and reduce the sugar absorption rate, thereby ameliorating postprandial hyperglycemia in favor of diet therapy of diabetes mellitus. Acarbose is used to treat NIDDM(non-insulin dependent diabetes mellitus) in combination with other oral medications. Besides, when combining with insuline, it could also effectively control diabetes mellitus in IDDM(insulin dependent diabetes mellitus). This study focused on the quality control of Acarbose tablet and compared it with the marketed reference preparations to ensure its safety and therapeutic effect. Part one TLC identification of AcarboseObjective: To establish a TLC method for the identification of Acarbose tablet.Methods: With n-butyl alcohol-ethanol-water(45:35:20) as developing solvent, the samples were applied and developed on one silica gel thin layer plate, then the plate was stained with thymol solution.Results: Conducted spots analysis was carried on after drying for 10-15 min.Conclusion: The color and position of principle spots from tested articles is the same with those of reference preparations. Part two Content determination of Acarbose tablet and related substances by HPLCObjective: To establish a HPLC method for the determination of Acarbose and the related substances.Methods: With amino silane bonded silica as filler, phosphate buffer-acetonitrile(28:72) as mobile phase, flow rate at 2 m L·min-1, column tempreture at 35℃, detection wavelength at 210 nm, after destructive treatment, the related substances in the tested preparations determined.Results: Retention time of Acarbose is 15.2 min, related substance and main peak reached the baseline separation with resolution more than 16.9.Conclusion: This method is simple, reliable, reproducible and has high specificity, it can provide a strong tool for quality control on Acarbose tablet. Part three Dissolution study on Acarbose tabletObjective: To investigate the dissolution rate and curve of Acarbose tablet under different conditions, optimize the methods in dissolution experiment, and evaluate its intrinsic quality.Methods: With water, 0.1 mol·L-1 HCl and phosphate buffer(p H=5.8) as dissolution mediums respectively and under different rotate speeds, determined the dissolution profile with HPLC-UV method, using f2 similarity factor to evaluate results.Results: In the three dissolution mediums(water, 0.1 mol·L-1 HCl and p H=5.8 phosphate buffer), tested articles have similar dissolution profiles with reference preparations.Conclusion: There is no significant difference in dissolution profiles between the tested articles and reference preparations.