HPLC法测定去羟肌苷咀嚼片中阿斯巴甜的含量  

Content Determination of Aspartame in Didanosine Chewable Tablets by HPLC

作　　者：陈炜[1] 仲平[1] 张军霞[1] 

机构地区：[1]河南省食品药品检验所,郑州450003

出　　处：《中国药房》2015年第3期371-373,共3页China Pharmacy

基　　金：全球基金项目--国家药品标准提高(No.GF2012-14)

摘　　要：目的：建立测定去羟肌苷咀嚼片中阿斯巴甜含量的方法。方法：采用高效液相色谱法。色谱柱为迪马C18,流动相为甲醇-水（39∶61,V/V）,流速为0.8 ml/min,柱温为25℃,检测波长为208 nm,进样量为20μl。结果：阿斯巴甜质量浓度在96.3~144.5μg/ml范围内与其峰面积积分值呈良好线性关系（r=0.999 7）;精密度、稳定性、重复性试验的RSD≤0.76%;平均回收率为98.8%,RSD为1.1%（n=3）。结论：该方法操作简便、准确度高,可用于去羟肌苷咀嚼片中阿斯巴甜的含量测定。OBJECTIVE： To establish a method for the content determination of aspartame in Didanosine chewable tablets. METHODS： HPLC method was adopted. The determination was performed on Diamonsil C18 column with mobile phase consisted of methanol-water （39 ： 61, V/V） at the flow rate of 0.8 ml/min. The column temperature was 25 h2, and detection wavelength was set at 208 nm. The injection volume was 20 μl. RESULTS： The linear range of aspartame was 96.3-144.5 μg/ml（r=0.999 7） with an average recovery of 98.8% （RSD：1.1%, n=3）. RSDs of precision, stability and reproducibility tests were all notmore than 0.76%. CONCLUSIONS： The method is convenient and accurate, and can be used for the content determination of aspartame in Didanosine chewable tablets.

关 键 词：阿斯巴甜 去羟肌苷咀嚼片 高效液相色谱法 含量测定 

分 类 号：R917[医药卫生—药物分析学]