毛细管气相色谱法测定盐酸利多卡因注射液的有关物质  

Determination of the Related Substances in Lidocaine Hydrochioride Injection by Capillary GC

作　　者：王春霞 盖成 李燕 苗会娟 Wang Chunxia;Ge Cheng;Li Yan;Miao Huijuan(Hehei Institute for Drug and Medi

机构地区：[1]河北省药品医疗器械检验研究院,石家庄050200

出　　处：《中国药师》2021年第10期1953-1957,共5页China Pharmacist

摘　　要：目的:建立毛细管气相色谱法测定盐酸利多卡因注射液有关物质的方法。方法:采用HP-1毛细管色谱柱(30 m×0.32 mm,1.00μm)以气相色谱法测定盐酸利多卡因注射液的有关物质。起始温度120℃,以10℃·min-1升温速率升温至210℃,维持15 min,检测器为氢火焰离子化检测器。结果:GC系统中所有杂质均可完全分离。杂质2,6-二甲基苯胺、杂质B和杂质H的浓度分别在0.08728~4.364μg·ml^(-1)(r=0.9999)、0.548~13.7μg·ml^(-1)(r=0.9998)、0.434~10.85μg·ml^(-1)(r=0.9995)范围内与峰面积成良好的线性关系。平均回收率分别为99.4%,99.1%,99.4%,RSD分别为1.4%,3.8%,4.4%(n=9)。3批样品中,2,6-二甲基苯均有检出,含量均为0.01%;杂质B、杂质H均未检出;其他单个杂质含量分别为0.3%,0.3%,0.2%。杂质总和分别为0.3%、0.3%、0.2%。结论:本方法准确可靠,可用于盐酸利多卡因注射液有关物质的测定。Objective:To establish a GC method for the related substances in lidocaine hydrochioride injection.Methods:The related substances in lidocaine hydrochioride injection were detected by an FID after the separation on an HP-1 capillary column(30 m×0.32 mm,1.00μm).The column temperature was 120℃,and then raised to 210℃at the rate of 10℃·min-1 for 15 mins.Results:The related substances in lidocaine hydrochioride injection were completely separated from the main constituents by GC.The standard curve of impurity 2,6-dimethylaniline,impurity B and impurity H was linear over the range of 0.08728-4.364μg·ml^(-1)(r=0.9999),0.548-13.7μg·ml^(-1)(r=0.9998)and 0.434-10.85μg·ml^(-1)(r=0.9995)with the average recovery of 99.4%,99.1%and 99.4%,and the RSDs of 1.4%,3.8%and 4.4%(n=9),respectively.The content of impurity 2,6-dimethylaniline in 3 batches was 0.1%,0.1%and 0.1%,respectively.Neither impurity B nor impurity H was detected out.The maximum single impurity was 0.3%,0.3%and 0.2%,respectively.The total impurities were 0.1%,0.1%and 0.1%,respectively.Conclusion:The method is accurate and reliable,and can be used for the quality control of lidocaine hydrochioride injection.

关 键 词：盐酸利多卡因注射液 有关物质 气相色谱法 

分 类 号：R927.1[医药卫生—药学]