HPLC法测定地高辛片的溶出度  

Determination of dissolution of dioxin tablets by HPLC

作　　者：李美芳[1] 庞学斌[1] 李玉兰[1] 

机构地区：[1]深圳市药品检验所,深圳518029

出　　处：《天津药学》2009年第6期8-10,共3页Tianjin Pharmacy

摘　　要：目的：建立地高辛片溶出度的HPLC测定方法。方法：色谱柱为Eclipse XDB C18（4．6mm×250mm，5μm），流动相为乙腈-水（32：68），流量为1ml／min，检测波长为220nm，柱温为30℃，进样量为80μl。结果：地高辛在0．99～24．83μg／ml浓度范围内，与峰面积呈良好的相关性（r=0．9999），平均回收率为99．2％（n=9），RSD为0．4％，最低检出量为0．03ng。结论：本法专属性强、灵敏度高、重现性好，结果准确，适用于地高辛片的质量控制。Objective： To establish an HPLC method to determine the dissolution of Dioxin tablets. Method： The determination was performed on an Eclipse XDB Cis column with a solution of acetonitrile -water（40： 60） as mobile phase; the flow rate was 1. 0 ml/min and the wavelength of detection was at 220 nm; the column temperature was 30℃ ; the injection volume was 80 μl. Results： A good linearity between the concentrations of the samples and their peak areas was shown from 0.99 to 24.83 μg/ml （r =0.999 9）. The average recovery rate was 100.1% from variously added amount of dioxin （RSD was 0.4% ,n =9）, and the minimal detectable concentration of Dioxin was 0.03 rig. Conclusions ： The method is accurate and sensitive. It can be used for control of dissolution of Dioxin tablets.

关 键 词：地高辛片 HPLC法 溶出度 

分 类 号：R927.11[医药卫生—药学]