电感耦合等离子体质谱法测定左氧氟沙星片中8种元素杂质的含量

目的:建立电感耦合等离子体质谱(ICP-MS)法测定左氧氟沙星片中钒(V)、铁(Fe)、钴(Co)、镍(Ni)、砷(As)、镉(Cd)、汞(Hg)、铅(Pb)8种元素杂质的含量.方法:取左氧氟沙星片剂研磨成粉,用微波消解法进行处理.采用ICP-MS法进行方法学验证及样品检测,测定模式为He模式,等离子体模式为通用模式,...

Content determination of 8 elemental impurities in levofloxacin tablets by inductively coupled plasma mass spectrometry method

Objective:To establish an inductively coupled plasma mass spectrometry(ICP-MS)for content determination of 8 elemental impurities(V,Fe,Co,Ni,As,Cd,Hg,Pb)in levofloxacin tablets.Methods:The levofloxacin tablets were ground into powder and treated by microwave digestion.ICP-MS method was used for methodological validation and sample detection.The measurement mode was He mode,and the plasma mode was general purpose mode.The sampling depth was 10.0 mm.The nebulizer gas flow was 1.03 L/min.The auxiliary gas flow was 0.90 L/min.The plasma gas flow was 15.0 L/min.The nebulizer pump speed was 0.10 r/min,and the temperature of atomizer chamber was 2℃.Results:Regression coefficients of the standard curves of eight elemental impurities were all more than 0.9990.The limits of detection and quantitation were all less than 10%of the limit concentration.The average recovery rates were within the range of 94.18%-100.75%,and RSD<5%(n=9).In repeatability,RSD<1%(n=6).The contents of 8 elemental impurities in 1 batch of reference preparation and 3 batches of test products all met the specified requirements.Conclusion:The established method for the determination of 8 elemental impurities in levofloxacin tablets has high sensitivity,accuracy and repeatability.It could be used for the control of the elemental impurities in levofloxacin tablets.