Content Determination of Seven Elemental Impurities in Estazolam Tablets by ICP-MS
Objective To establish an inductively coupled plasma-mass spectrometry(ICP-MS)method for the content determination of category 1 elements[arsenic(As),cadmium(Cd),hydrargyrum(Hg),and lead(Pb)],and category 2A elements[cobalt(Co),nickel(Ni),and vanadium(V)]in Estazolam Tablets.Methods The samples were pre-treated with the nitric acid.The radio frequency(RF)power of the plasma was 1 500 W,the flow rate of the atomized gas was 0.92 L/min,the speed of the peristaltic pump was 25 r/min,the crash mode was kinetic energy discrimination(KED)mode,the collision gas was helium with a flow rate of 3.8 mL/min.The matrix effect and interference were corrected with indium(115In)and bismuth(209Bi)elements as internal standards.Results The linear ranges of As,Cd,Hg,Pb,Co,Ni,and V elements were 0-4.5 ng/mL,0-1.5 ng/mL,0-9.0 ng/mL,0-1.5 ng/mL,0-15.0 ng/mL,0-60.0 ng/mL,and 0-30.0 ng/mL(r≥0.999 4,n = 5),respectively.The RSDs of the repeatability and intermediate precision test results were lower than 4%(n = 6).The recovery rates of the above seven elemental impurities were 96.33%,90.02%,89.46%,105.08%,104.43%,99.07%,and 106.04%,with RSDs of 4.48%,4.42%,3.19%,4.58%,2.16%,2.43%,and 1.87%(n = 9),respectively.The impurity content of seven elemental impurities in 20 batches of samples was far below the specified limits.Conclusion The method is simple and accurate,which can be used for the content determination of category 1 and 2A elemental impurities in Estazolam Tablets.
万方数据
维普
