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离子抑制色谱法测定注射用醋酸奥曲肽中乙酸的含量
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| 篇名： | 离子抑制色谱法测定注射用醋酸奥曲肽中乙酸的含量 |
| TITLE： | |
| 摘要： | 目的：采用离子抑制色谱法测定注射用醋酸奥曲肽中乙酸的含量，为药典标准的完善提供参考。方法：色谱柱为Rezex ROA-Organic Acid H+，流动相为0.002 5 mol/L硫酸溶液，流速为0.5 ml/min，检测波长为210 nm，柱温为45 ℃，进样量为100 μl。结果：乙酸的检测质量浓度线性范围为0.394 4～78.89 μg/ml（r＝0.999 9）；定量限为197.2 ng/ml，检测限为78.89 ng/ml；精密度、稳定性、重复性试验的RSD＜2％；加样回收率为104.71％～109.78％（RSD＝1.34％，n＝9）。结论：该方法环保、简便、准确度和精密度良好，适用于测定注射用醋酸奥曲肽中乙酸的含量。 |
| ABSTRACT： | OBJECTIVE： To determine the content of acetic acid in Octreotide acetate for injection by IEC，and provide reference for the improvement of pharmacopoeia standards. METHODS： The column was Rezex ROA-Organic Acid H+ with mobile phase of 0.002 5 mol/L sulfuric acid at a flow rate of 0.5 ml/min， the detection wavelength was 210 nm， column temperature was 45 ℃， and injection volume was 100 μl. RESULTS： The linear range of acetic acid was 0.394 4 μg/ml-78.89 μg/ml （r＝0.999 9）； RSDs of precision， stability and reproducibility tests were all lower than 2％； the limit of quantification was 197.2 ng/ml，and limit of detection was 78.89 ng/ml； recovery was 104.71％-109.78％（RSD＝1.34％， n＝9）. CONCLUSIONS： The method is environmental and simple with good accuracy and precision， and suitable for the content determination of acetic acid in Octreotide acetate for injection. |
| 期刊： | 2016年第27卷第27期 |
| 作者： | 李婧华，刘桂霞，李盼盼，王智亮，姚静，李卓荣，山广志 |
| AUTHORS： | LI Jinghua，LIU Guixia，LI Panpan，WANG Zhiliang，YAO Jing，LI Zhuorong，SHAN Guangzhi |
| 关键字： | 离子抑制色谱法；注射用醋酸奥曲肽；乙酸 |
| KEYWORDS： | IEC； Octreotide acetate for injection； Acetic acid |
| 阅读数： | 401 次 |
| 本月下载数： | 6 次 |
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