离子抑制色谱法测定醋酸曲普瑞林注射液中醋酸的含量  

Determination of acetic acid in triptorelin acetate injection by IEC

作　　者：李婧华[1] 宗艳平 王智亮[3] 姚静[4] 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]辽宁医学院药学院,锦州121000 [3]山东省潍坊市人民医院,潍坊261041 [4]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2016年第5期863-867,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：科技部新药创制重大专项平台(2012ZX09301002-001-019)

摘　　要：目的:利用离子抑制色谱法测定醋酸曲普瑞林注射液中醋酸的含量。方法:采用Rezex ROAOrganic Acid H^+(7.8 mm×300 mm)色谱柱,以0.002 5 mol·L^(-1)硫酸为流动相,流速0.5 m L·min^(-1),柱温45℃,检测波长210 nm,醋酸的含量按外标法以峰面积计算。结果:醋酸的检测限为78.89 ng·m L^(-1),定量限为197.2 ng·m L^(-1);醋酸质量浓度在0.394 4～78.89 g·m L^(-1)范围内线性关系良好(r=0.999 9);平均回收率(n=9)为98.69%,RSD为0.51%;3批醋酸曲普瑞林注射液中醋酸含量分别为23.99、22.38和22.96 g·m L^(-1)。结论:本方法环保、简便,准确度及精密度良好,适用于醋酸曲普瑞林注射液中醋酸的定量分析。Objective：To establish an ion-exclusion chromatography（IEC）method to determine the content of acetic acid in triptorelin acetate injection.Methods：Rezex ROA-Organic Acid H＋（7.8 mm×300 mm）column was applied for the study.The mobile phase consisted of 0.002 5 mol·L^-1 sulfuric acid at a flow rate of 0.5 m L·min^-1.The column temperature was 45℃,and the detection wavelength was 210 nm.The assay was quantitatively completed by external standard method.Results：The LOD of acetic acid was 78.89 ng·m L^-1,and the LOQ was 197.2 ng·m L^-1.The linearly dependent coefficient was 0.999 9 when the content of acetic acid ranged from 0.394 4 g·m L^-1 to 78.89 g·m L^-1.The average recovery（n=9）was 98.69% with a RSD of 0.51%.The content of acetic acid in 3 batches of triptorelin acetate injection were 23.99 g·m L^-1,22.38 g·m L^-1,and 22.96 g·m L^-1,respectively.Conclusion：The established method is environmental-friendly,concise,accurate and precise,which can be applied to the content determination of acetic acid in triptorelin acetate injection.

关 键 词：离子抑制色谱法(IEC) 醋酸曲普瑞林注射液 醋酸 多肽药物 含量测定 

分 类 号：R917[医药卫生—药物分析学]