Rapid Quantitation of Seven Elemental Impurities in Cinnarizine Tablets by X-Ray Fluorescence Spectrometry
Objective To establish a rapid quantitation method for cadmium(Cd),lead(Pb),arsenic(As),mercury(Hg),cobalt(Co),vanadium(V)and nickel(Ni)in Cinnarizine Tablets,and to assess their risk.Methods The contents of seven elemental impurities in 17 batches of Cinnarizine Tablets from 11 manufacturers were determined by energy dispersive X-ray luorescence spectrometry without sample pretreatment.The voltage was 50 kV,the current was 100 μA,the atmosphere was air,and the test time was 3 100 s.Results The linear ranges of Cd,Pb,As,Hg,Co,V and Ni were 0-16.6 mg/kg,0-16.6 mg/kg,0-50 mg/kg,0-100 mg/kg,0-166.6 mg/kg,0-333.5 mg/kg,and 0-667 mg/kg(r≥0.999 0),respectively.The average recovery rates of seven elemental impurities were 93.75%,80.00%,90.17%,82.28%,112.79%,115.60%,and 104.71%,respectively.The limits of quantification of seven elemental impurities were 0.578,1.090,0.281,0.625,0.364,1.747,and 1.534 mg/kg,respectively.The contents of the seven elements mentioned above in 17 batches of Cinnarizine Tablets were all below the control threshold,and no risk was found.Conclusion The method is simple,it can directly and quickly quantify the seven elemental impurities in Cinnarizine Tablets,which is suitable for the risk assessment of elemental impurities in oral solid preparations of Cinnarizine Tablets.
energy dispersive X-ray luorescence spectrometryelemental impuritiesCinnarizine Tablets
万方数据
维普
