Analysis of Impurity Degradation and Dathways in the Destructive Test of Nicorandil API
Objective:To investigate the effects of temperature,humidity,strong acid and strong base on the forced degradation of nicorandil through destructive experiments,and to explore the pathways and mechanisms of impurity degradation of nicorandil.Methods:High performance liquid chromatography area normalization was used,with octadecyl bonded silica gel as the filler(SunFire C18(4.6×150 mm,3.5 μm)),and 0.01 mol/L diammonium phosphate acetonitrile(90∶10)(adjusted to pH 7.0 with phosphoric acid)as the mobile phase;The column temperature was 25℃;The detection wavelength was 262 nm;The flow rate was 0.8 mL/min.Results:In aqueous solution,nicorandil first produces impurity SG-210,With the prolongation of the destruction time and the increase of temperature,at the same time as impurity SG-210 was generated,impurity SG-210 also opened its cycle and converted into impurity SG-100.Nicorandil powder mainly generated polymers under high-temperature drying conditions,but impurities SG-210,SG-100,and nicorandil dimer were generated under high temperature and humidity conditions,and nicorandil is relatively stable to strong acids and oxygen.Conclusion:The chemical properties of nicorandil were mainly affected by temperature and moisture,as the temperature increased,the amount and rate of impurities produced increase,nicorandil exhibited different degradation pathways in solution and powder states.
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