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作 者:刘倩云 丁极武 李恩澳 陆荣政 刘荣华[1] LIU Qianyun;DING Jiwu;LI En’ao;LU Rongzheng;LIU Ronghua(School of Pharmacy,Jiangxi University of Chinese Medicine,Nanchang 330004,China;Nanjing Zenkom Pharmaceutical Co.,Ltd,Nanjin 210038,China)
机构地区:[1]江西中医药大学药学院,南昌330004 [2]南京正科医药股份有限公司,南京210038
出 处:《中国药品标准》2024年第5期501-505,共5页Drug Standards of China
摘 要:目的:建立复方醋酸钠林格注射液中钠、钾、镁、钙离子含量的原子吸收分光光度法-火焰法测定方法。方法:采用A3AFG-12型A3原子吸收分光光度计和XS205DU型、XP6型电子天平,以氯化铯作为测定钠离子和钾离子时的电离抑制剂,氯化镧为测定镁离子和钙离子时电离抑制剂,分别在589.3、766.5、285.2、422.7 nm处测定钠、钾、镁、钙离子含量,并进行方法学验证。结果:4种离子分别在0.15~1.20、0.2~1.6、0.05~0.4、1.014~5.069μg·mL^(-1)的浓度范围内线性关系良好,相关系数分别为r=0.9996、r=0.9993、r=0.9996、r=0.9990;4种离子平均回收率分别为98.5%,98.1%,93.2%,95.0%;测定注射液样品5批,钠、钾、镁、钙离子含量分别在3.186~3.221、0.155~0.160、0.023~0.026、0.056~0.059 mg·mL^(-1)范围内。结论:经方法学验证,所建立的方法重现性强、准确度高,适用于复方醋酸钠林格注射液中钠、钾、镁、钙离子的含量测定。Objective:To establish an atomic absorption spectrophotometry and flame method for the determination of sodium,potassium,magnesium and calcium ions in compound sodium acetate ringer injection.Methods:The A3AFG-12 A3 atomic absorption spectrophotometer,XS205DU and XP6 electronic balances were used.Cesium chloride was used as the ionization inhibitor for the determination of sodium and potassium ions,and lanthanum chloride was used as the ionization inhibitor for the determination of magnesium and calcium ions.The contents of sodium,potassium,magnesium and calcium were determined at 589.3,766.5,285.2 and 422.7 nm,respectively,and the methodol was verified.Results:Four ions had good linear relationships in the concentration range of 0.15-1.20,0.2-1.6,0.05-0.4,and 1.014-5.069μg·mL^(-1),and the correlation coefficients were r=0.9996,r=0.9993,r=0.9996,r=0.9990,respectively.The average recoveries were 98.5%,98.1%,93.2%and 95.0%,respectively.The contents of sodium,potassium,magnesium and calcium ions in 5 batches of injection samples were measured in the range of 3.186-3.221,0.155-0.160,0.023-0.026 and 0.056-0.059 mg·mL^(-1),respectively.Conclusion:The established method has high reproducibility and accuracy,and is suitable for the determination of sodium,potassium,magnesium and calcium in compound sodium acetate ringer injection.
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