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
x
请在关注微信后,向客服人员索取文件
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: | 326 次 |
本月下载数: | 9 次 |
* 注:未经本站明确许可,任何网站不得非法盗链资源下载连接及抄袭本站原创内容资源!在此感谢您的支持与合作!