摘要
目的:建立高效液相色谱法测定恩替卡韦钠片的含量。方法:采用 Capcell Park C_(18)色谱柱(4.6 mm×200 mm,5μm),以甲醇-水-三乙胺(20:80:0.1)为流动相,流速为1.0 mL·min^(-1),检测波长243 nm,柱温为室温。结果:恩替卡韦钠在3.0～200μg·mL^(-1)(r=0.9992,n=6)范围内呈良好的线性关系;最低检测限为0.01 ng;高、中、低3种不同浓度的平均回收率为100.1%～100.6%,精密度为0.48%。结论:本方法简便快速结果准确可靠,可用于该药物质量标准研究。
Objective ：To establish a method for determination of entecavir sodium tablets. Method：A column of Capcell Park ClS （4.6mm×200mm,5μm） at room temperature,a mobile phase consisting of methanol -watertriethylamine （20： 80： 0. 1 ） with a flow rate of 1.0 mL· min^- 1, and a UV detector at 243 nm were adopted. Results： The linear range of the determination by RP - HPLC was 3.0 - 200μg·mL^ - 1. （ r = 0. 9992, n = 6 ） ; The least detective range was 0. 01 ng;The average recovery was from 100. 1% to 100. 6% with a precision of 0. 48% were obtained. Conclusion：A simple and accurate method is established for determination of entecavir sodium, and can be used for quality control of entecavir sodium tablets.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2007年第8期1267-1268,共2页
Chinese Journal of Pharmaceutical Analysis
