离子抑制色谱法测定注射用醋酸奥曲肽中乙酸的含量  

Content Determination of Acetic Acid in Octreotide Acetate for Injection by IEC

作　　者：李婧华[1] 刘桂霞[1] 李盼盼[1] 王智亮[2] 姚静[3] 李卓荣[1] 山广志[1] 

机构地区：[1]中国医学科学院医药生物技术研究所,北京100050 [2]潍坊市人民医院,山东潍坊261041 [3]中国食品药品检定研究院,北京100050

出　　处：《中国药房》2016年第27期3867-3869,共3页China Pharmacy

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RezexROA—OrganicAcid H＋，流动相为0．0025mol/L硫酸溶液，流速为0．5ml／min，检测波长为210nm，柱温为45℃，进样量为100μl。结果：乙酸的检测质量浓度线性范围为0．3944～78．89μg/ml（r=0．9999）；定量限为197．2ng／ml，检测限为78．89ng／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。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 colunm 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 4μg/m1-78.89 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%-209.78% （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. KEYWORDS IEC; Octreotideacetate for injection; Aceticacid

关 键 词：离子抑制色谱法 注射用醋酸奥曲肽 乙酸 

分 类 号：R917[医药卫生—药物分析学]