离子对高效液相色谱法分离测定单唾液酸神经节苷脂的含量  

Ion Pair HPLC Determination of Content of Monosialogangliosides(GM1)

作　　者：郑永彪[1] 范慧红[2] 徐康森[2] 吴如金[3] 

机构地区：[1]青海省药品检验所,西宁810000 [2]中国药品生物制品检定所,北京100050 [3]中国药科大学,南京210009

出　　处：《药物分析杂志》2004年第2期135-136,共2页Chinese Journal of Pharmaceutical Analysis

基　　金：北京市自然科学基金资助项目(批准号:7032041)

摘　　要：目的:建立一种不经衍生而直接分离测定单唾液酸神经节苷脂(GM1)的方法。方法:离子对高效液相色谱法。色谱柱:Lichrospher 100NH2(250mm×4 mm,5μm);流动相:乙腈-0.1 mol·L-1磷酸溶液(66:34);流速:1.0 mL·min-1;进样量:10μL;检测波长为205nm。结果:不经衍生而直接分离测定GM1,及其制剂的含量,平均回收率(n=3)分别为98.92%(RSD为1.6%),99.16%(RSD为0.9%),99.60%(RSD为1.1%),GM1浓度在0.82-2.4mg·mL-1范围内与峰面积呈良好的线性关系(r=0.9998)。结论:本法简便、快速、准确,适用于该药品的生产及临床应用中的质量控制。Objective:To establish a method using ion pair HPLC for determining the content of GM1 without derivation. Method: A Lichrospher 100NH2column(250 mm×4 mm,5μm)was used,the mobile phase was acetonitrile -0.1 mol·L -1 phosphoric acid solution (66:34) ,the flow rate was 1.0 mL·min-1 ,the injection volume was 10 μL,the UV detection wavelength was 205 nm. Results:It can determine the content of GM1 without derivatived,the average recoveries(n=3) were 98. 92% (RSD=1.6%), 99.16% (RSD=0.9%) , 99. 60% (RSD=1.1%) respectively , the calibration curves were linear in the range of 0. 82-2. 4 mg·mL-1. Conclusion: This method is simple,quick,accurate and very suitable for the quality control of the drug in manufacture and clinical application.

关 键 词：离子对高效液相色谱法 单唾液酸神经节苷脂 含量测定 质量控制 色谱条件 

分 类 号：R927.2[医药卫生—药学] O657.72[理学—分析化学]