首页|ICP-MS法测定艾拉戈克钠中14种元素杂质的含量

ICP-MS法测定艾拉戈克钠中14种元素杂质的含量

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目的:建立电感耦合等离子体质谱(ICP-MS)法测定艾拉戈克钠中铅(Pb)、镉(Cd)、汞(Hg)、砷(As)、钴(Co)、钒(V)、镍(Ni)、铬(Cr)、锰(Mn)、铁(Fe)、硅(Si)、硼(B)、铝(Al)、钯(Pd)的残留量。方法:采用微波消解法对样品进行前处理，以铋(Bi)、锗(Ge)、铟(In)和钪(Sc)为内标，采用动能歧视的碰撞模式(KED)，石英同心雾化器进样，射频正向功率为1300W，雾化气流速为0。9L·min-1，等离子体气流速为17。0L·min-1，辅助气流速为1。2L·min-1。结果:14种待测元素线性关系良好(r≥ 0。999);定量限在9。509 ×10-4～9。029 μg·g-1;平均加样回收率(n=9)在83。21％～126。5％;重复性试验RSD(n=6)均≤4。0％。建立的方法准确且灵敏度高，可用于艾拉戈克钠中14种元素杂质的痕量控制。结论:所建立的方法操作简便，方法专属性好，定量准确，满足艾拉戈克钠中14种元素杂质的质量控制要求。
Determination of 14 Elemental Impurities in Elagolix Sodium by ICP-MS
Objective:To establish an inductively coupled plasma mass spectrometry(ICP-MS)method for the quantification of lead(Pb),cadmium(Cd),mercury(Hg),arsenic(As),cobalt(Co),vanadium(V),nickel(Ni),chromium(Cr),manganese(Mn),iron(Fe),silicon(Si),boron(B),aluminum(Al)and palladium(Pd)in elagolix.Methods:Samples were pretreated using microwave digestion,with bismuth(Bi),germanium(Ge),indium(In)and scandium(Sc)as internal standards.Energy discrimination(KED)collision mode was employed,along with a glass concentric nebulizer for sampling,RF forward power at 1300 W,nebulizer gas flow rate at 0.9 L·min-1,plasma gas flow rate at 17.0 L·min-1 and auxiliary gas flow rate at 1.2 L·min-1.Re-sults:Good linear relationships were achieved for the 14 elements to be tested(r ≥ 0.999).The limits of quantification were 9.509 × 10-4-9.029 μg·g-1.The average recoveries(n=9)ranged from 91.19％to 126.5％,and the relative standard deviations(RSD,n=6)were all≤4.0％.Conclusion:The established method is simple,specific,accurate,and meets the quality control requirements for the determination of the 14 ele-mental impurities in elagolix.

Elagolix sodiumInductively Coupled Plasma Mass SpectrometryMicrowave DigestionEle-mental Impurities

田帅华、田凤艳、刘红伟、宗在伟

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江苏奥赛康药业有限公司,南京 211112

艾拉戈克钠 电感耦合等离子体质谱 微波消解 元素杂质

2024

药学与临床研究
江苏省药学会

药学与临床研究

CSTPCD
影响因子：0.95
ISSN：1673-7806
年,卷(期)：2024.32(6)