Degradation Tests of Cimetidine Tablets and Investigation of Degradation Products
Objective:To study the forced degradation of cimetidine tablets under the conditions of light,high temperature,acid,alkali and oxidation.Methods:Liquid chromatography was used to detect degradation products,including octadecylsilane bonded silica gel as the filler;methanol-water(240∶760)(containing 0.3 mL of phosphoric acid and 0.94 g of sodium hexane sulfonate per 1000 mL)as the mobile phase;the detection wavelength at 220 nm;the flow rate at 1.0 mL·min-1;and the injection volume at 20 μL.Results:It was determined that the acid degradation product was impurity C,the oxidation degradation product was impurity E,while the alkali high temperature degradation product,2-cyano-1-(2-mercap-toethyl)-3-methylguanidine,was not detected in the forced degradation products.Conclusion:The struc-tures of the degradation products of cimetidine by forced alkali and oxidation was successfully inferred,and their production pathways were clarified,which provided the basis for the stability study and quality control of cimetidine tablets.
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