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微波消解-电感耦合等离子体质谱法测定棓丙酯氯化钠注射液中8种金属元素的含量

钟振华 涂明珠 万星 夏红英 程奇珍

中国药房2018,Vol.29Issue(12):1612-1616,5.
中国药房2018,Vol.29Issue(12):1612-1616,5.DOI:10.6039/j.issn.1001-0408.2018.12.07

微波消解-电感耦合等离子体质谱法测定棓丙酯氯化钠注射液中8种金属元素的含量

Content Determination of 8 Metal Elements in Propylgaclate and Sodium Chloride Injection by Microwave Digestion-inductively Coupled Plasma Mass Spectrometry

钟振华 1涂明珠 1万星 1夏红英 1程奇珍1

作者信息

  • 1. 江西省药品检验检测研究院/江西省药品与医疗器械质量工程技术研究中心,南昌 330029
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摘要

Abstract

OBJECTIVE:To establish a method for the content determination of 8 metal elements in Propylgaclate and sodium chloride injection. METHODS:Microwave digestion-inductively coupled plasma mass spectrometry(ICP-MS) was adopted. Radiofrequency power was 1 530 W;cooling temperature was 4 ℃;collision gas was He gas;carrier gas was argon;flow rate of carrier gas was 1.08 L/min;integration time was 0.3 s;plasma gas flow rate was 15 L/min;the vacuum degree of quadrupole was 3.04×10-4 Pa;sampling cone aperture was 1.0 mm;interception cone aperture was 0.4 mm;the speed of sampling was 0.3 rps;data collection was repeated for 3 times. The microwave digestion power is 1 600 W,and the heating process is heated to 160℃at room temperature for 30 min,and maintained at 5 min,and then heated to 190 ℃ at a temperature of 5 ℃/min and maintained 45 min. RESULTS:The linear range of Mg and Al were 1-250 ng/mL;the linear range of Cr,Mn,Fe,Cu,Zn,Cd were 1-100 ng/ mL(all r≥0.999 0). The limits of detection were 0.063 6-1.785 0 ng/mL. RSDs of precision,stability and reproducibility tests were all lower than 4%. The recoveries were 89.65%-105.60%(RSD were 1.57%-3.98%,n=9). RSDs of durablity were all lower than 12%. CONCLUSIONS:The method is simple,accurate,precise,stable,reproducible and durable. It can be used for content determination of 8 metal elements in Propylgaclate and sodium chloride injection.

关键词

棓丙酯氯化钠注射液/微波消解-电感耦合等离子体质谱法/金属元素

Key words

Propylgaclate and sodium chloride injection/Microwave digestion-inductively coupled plasma mass spectrometry/Metal elements

分类

医药卫生

引用本文复制引用

钟振华,涂明珠,万星,夏红英,程奇珍..微波消解-电感耦合等离子体质谱法测定棓丙酯氯化钠注射液中8种金属元素的含量[J].中国药房,2018,29(12):1612-1616,5.

基金项目

国家药品抽验项目(2015) (2015)

江西省食品药品监督管理局科研项目(No.2016YP16) (No.2016YP16)

中国药房

OA北大核心CSTPCD

1001-0408

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