原子吸收光谱法测定注射用哌拉西林钠中钠含量
Determination of sodium content in piperacillin sodium for injection by atomic absorption spectrometry
李佳蕊 1韩彬 2王强 2王巧 3高燕霞1
作者信息
- 1. 河北省药品医疗器械检验研究院,石家庄 050021;河北医科大学,石家庄 050017
- 2. 河北省药品医疗器械检验研究院,石家庄 050021
- 3. 河北医科大学,石家庄 050017
- 折叠
摘要
目的 建立原子吸收分光光度法测定注射用哌拉西林钠中钠含量,同时对国产制剂成盐情况进行评价.方法 原子吸收分光光度法(atomic absorption spectrophotometry,AAS).采用钠元素空心阴极灯光源;空气-乙炔火焰原子化器;检测波长589.0 nm;4％氯化铯溶液作为电离抑制剂,临用稀释50倍.结果 原研企业4批次样品中钠含量平均值4.46％,16家国内生产企业204批次样品中钠元素含量平均值4.41％,均高于理论值4.26％,不同生产企业的产品钠含量差异大,多批次超出理论值±5％范围.结论 该方法操作简单、专属性强、结果准确,可通过钠含量的测定,对哌拉西林钠原料成盐工艺水平进行评估.
Abstract
Objective This study established an atomic absorption spectrophotometry(AAS)method for the determination of sodium content in piperacillin sodium for injection and evaluated the salt formation of domestic piperacillin sodium.Methods AAS with a sodium-element hollow cathode light source and an air-acetylene flame atomizer was utillized;the detection wavelength was 589.0 nm,and 4％cesium chloride solution was used as the ionization inhibitor,which was diluted 50 times for detection.Results The average sodium content in 4 batches of brand-name products was 4.46％,and the average sodium content in 204 batches of generic drugs from 16 domestic manufacturers was 4.41％,both higher than the theoretical value of 4.26％.The sodium content was significantly different among the domestic manufacturers,and many batches exceeded the theoretical value of 士5％.Conclusion The method was simple,specific and accurate.It could be used to evaluate the technological level of piperacillin sodium raw materials by determining the sodium content.
关键词
哌拉西林钠/钠含量/质量分析/工艺控制Key words
Piperacillin sodium/Sodium content/Quality analysis/Process control引用本文复制引用
出版年
2024
NETL
NSTL
万方数据