目的: 建立盐酸罗哌卡因注射液中29种具有潜在风险的元素杂质镉、铅、砷、汞、钴、钒、镍、铊、硒、银、金、钯、铱、锇、铑、钌、铂、锂、锑、钡、钼、铜、锡、铬、铝、铁、锌、硼、硅的电感耦合等离子体质谱检测方法并对相容性进行了考察。方法: 以硝酸-盐酸-水(4∶1∶95)稀释样品,采用电感耦合等离子体质谱(ICP-MS)法对盐酸罗哌卡因注射液中元素杂质进行含量分析,运用碰撞模式消除双电荷干扰。结果: 29种元素杂质的检测限为0.013 8~361.1 ng·mL-1,加标回收率在93.8%~126. 0%,30批样品中29种元素杂质含量均未超过限度。结论: 本方法准确,灵敏度高,简便可行,可以为盐酸罗哌卡因注射液元素杂质评估和控制提供有力的技术保障。
Objective: To establish a inductively coupled plasma mass spectrometry (ICP-MS) method for the determination of 29 types of element impurities with potential risks in ropivacaine hydrochloride injection,including Cd, Pb, As, Hg, Co, V, Ni, Tl, Se, Ag, Au, Pd, Ir, Os, Rh, Ru, Pt, Li, Sb, Ba, Mo, Cu, Sn, Cr, Al, Fe, Zn, B and Si, and to investigate their compatibility. Methods: Nitric acid- hydrochloric acid-water(4∶1∶95)dilution were adopted to prepare the samples, collision mode was used to eliminate double charge interference, the content of 29 impurity elements in ropivacaine hydrochloride injection were analyzed by an ICP-MS method. Results: The detection limits of the 29 impurity elements were 0.013 8-361.1 ng·mL-1, and the spiked recoveries were in the range of 93.8%-126.0%. The contents of the 29 kinds of impurity elements in 30 batches of samples did not exceed the limits. Conclusion: This method is accurate, sensitive, simple and feasible, and can provide strong technical support for the evaluation and control of potential elemental impurities in ropivacaine hydrochloride injection.
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