摘要
建立测定他克莫司缓释胶囊含量的方法,并应用于溶出度测定。通过对检测波长、色谱柱、流动相比例、流动相流速和柱温等影响因素进行考察,确定了色谱条件,检测波长为210 nm,色谱柱为Agilent Eclipse XDB-C8柱(4.6 mm×150 mm,5µm),流动相为乙腈-水-6%磷酸(68:32:0.1),流速为0.6 mL·min^(-1),柱温为45℃。方法学验证结果表明,方法专属性强,精密度好(RSD=0.19%,n=6),准确度高(3种浓度平均回收率分别为98.72%、99.77%、100.23%,回收率RSD<1%)。他克莫司缓释胶囊在给定溶出条件下缓慢释放,前4 h溶出速度较快,8 h后溶出速度缓慢,于18 h达到溶出平台。
To establish a method for determining the content of tacrolimus capsules and applied to the determination of disso⁃lution.By studying the impact of detection wavelength,column,mobile phase ratio,mobile phase velocity and column tem⁃perature,the chromatographic conditions were determined,the detection wavelength was 210 nm,the column was Agilent Eclipse XDB-C8(4.6 mm×150 mm,5μm),the mobile phase was acetonitrile,water,and 6%phosphoric acid(68:32:0.1)at a flow rate of 0.6 mL·min^(-1),the column temperature was 45°C.The results of methodology verification show that,the method has strong specificity,good precision(RSD 0.19%,n=6),and high accuracy(the average recoveries of the three concentrations were 98.72%,99.77%and 100.23%,with RSD less than 1%).Tacrolimus sustained-release capsules were released slowly under the given dissolution conditions,and the dissolution rate was faster in the first 4 h and slower after 8 h,reaching the dissolution platform at 18 h.
作者
揭小玲
周阿容
詹清
林梦丹
郑孝贤
王海龙
Jie Xiao-ling;Zhou A-rong;Zhan Qing;Lin Meng-dan;Zheng Xiao-xian;Wang Hai-long(Fujian Institute of Microbiology,Fuzhou,Fujian 350007,China)
出处
《福建分析测试》
CAS
2023年第4期58-62,共5页
Fujian Analysis & Testing
基金
福建省属公益类科研院所基本科研专项(2019R1005-3)。
