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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
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| 篇名： | 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 |
| TITLE： | |
| 摘要： | 目的：采用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。方法：分析柱为Thermo Dionex IonPacTM AS11-HC，流动相为氢氧化钾溶液（梯度洗脱），流速为1.0 mL/min，柱温为35 ℃，进样量为20 μL，检测器为抑制型电导检测器。结果：枸橼酸检测质量浓度线性范围为0.115 7～74.05 μg/mL（r＝0.999 5）；定量限为0.115 0 μg/mL，检测限为0.040 0 μg/mL；精密度、稳定性、重复性试验的RSD＜2.0％；加样回收率为99.6％～101.5％（RSD＝0.68％，n＝9）。结论：该方法环保、简便，准确度和精密度良好，适用于枸橼酸芬太尼原料药及注射液中枸橼酸的含量测定。 |
| ABSTRACT： | OBJECTIVE： To determine the contents of citric acid in fentanyl citrate raw materials and its injection by ion chromatography. METHODS： The determination was performed on Thermo Dionex IonPacTM AS11-HC column with mobile phase consisted 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 0.115 7-74.05 μg/mL（r＝0.999 5）. The limit of quantitation was 0.115 0 μg/mL， and the limit of detection was 0.040 0 μg/mL； RSDs of precision， 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. |
| 期刊： | 2017年第28卷第18期 |
| 作者： | 马迅，李盼盼，刘桂霞，宗艳平，孙伟，山广志，陈华，南楠 |
| AUTHORS： | MA Xun，LI Panpan，LIU Guixia，ZONG Yanping，SUN Wei，SHAN Guangzhi，CHEN Hua，NAN Nan |
| 关键字： | 枸橼酸芬太尼；枸橼酸；含量测定；离子色谱法 |
| KEYWORDS： | Fentanyl citrate； Citric acid； Content determination； Ion chromatography |
| 阅读数： | 359 次 |
| 本月下载数： | 9 次 |
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