中国药房2017，Vol.28Issue(18)：2536-2538,3.DOI:10.6039/j.issn.1001-0408.2017.18.25
离子色谱法测定枸橼酸芬太尼原料药和注射液中枸橼酸的含量
Contents Determination of Citric Acid in Fentanyl Citrate Raw Materials and Its Injection by Ion Chroma-tography
摘要
Abstract
OBJECTIVE:To determine the contents of citric acid in fentanyl citrate raw materials and its injection by ion chro-matography. METHODS:The determination was performed on Thermo Dionex IonPacTM AS11-HC column with mobile phase con-sisted of potassium hydroxide (gradient elution) at the flow rate of 1.0 mL/min. The column temperature was 35 ℃,and sample size was 20 μL. The detector was suppressed conductivity detector. RESULTS:The linear range of citric acid were 0.1157-74.05 μg/mL(r=0.9995). The limit of quantitation was 0.1150 μg/mL,and the limit of detection was 0.0400 μg/mL;RSDs of preci-sion,stability and reproducibility tests were all lower than 2.0%;the average recoveries were 99.6%-101.5%(RSD=0.68%,n=9). CONCLUSIONS:The method is environmentally-friendly and simple with good accuracy and precision,and suitable for the contents determination of citric acid in fentanyl citrate raw materials and injection.关键词
枸橼酸芬太尼/枸橼酸/含量测定/离子色谱法Key words
Fentanyl citrate/Citric acid/Content determination/Ion chromatography分类
医药卫生引用本文复制引用
马迅,李盼盼,刘桂霞,宗艳平,孙伟,山广志,陈华,南楠..离子色谱法测定枸橼酸芬太尼原料药和注射液中枸橼酸的含量[J].中国药房,2017,28(18):2536-2538,3.基金项目
中国医学科学院与健康科技创新工程系统创新团队基金(No.2016-I2M-3-010) （No.2016-I2M-3-010）
