反相离子对色谱法测定四氢姜黄素的含量  

Ion-pairing RP-HPLC method to determine tetrahydrocurcumin

作　　者：朱宁[1,2] 凌海燕[2] 杨安东[2] 赵军宁[2] 李小芳[1] ZHU Ning;LING Hai-yan;YANG An-dong;ZHAO Jun-ning;LI Xiao-fang(School of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China;Sichuan Academy of Chinese Medicine Science,Chengdu 610041,China)

机构地区：[1]成都中医药大学药学院,成都611137 [2]四川省中医药科学院,成都610041

出　　处：《药物分析杂志》2022年第5期773-779,共7页Chinese Journal of Pharmaceutical Analysis

基　　金：科技部重大新药创制专项资助项目(2018ZX09731-008)。

摘　　要：目的:建立测定四氢姜黄素含量的离子对反相高效液相色谱法。方法:采用Agilent ZORBAX Extend-C_(18)(150 mm×4.6 mm,5.0μm)色谱柱,以乙腈-0.05%氨水(含10 mmol·L^(-1)十二烷基三甲基氯化铵)(38∶62)为流动相进行等度洗脱,检测波长288 nm,柱温25℃。结果:四氢姜黄素进样量在0.149~7.452μg范围内与峰面积线性关系良好(r=0.9999),平均回收率为99.9%(RSD=0.68%);检测限和定量限分别为0.011μg和0.044μg,且四氢姜黄素与杂质能够完全分离。按本法测得3批原料药含量分别为98.6%、98.3%和98.3%。结论:本含量测定方法简单、快速,专属性好,能够满足四氢姜黄素原料药含量测定的要求。Objective:To establish an ion-pairing reverse phase HPLC determination method for detecting the concentration of tetrahydrocurcumin in active pharmaceutical ingredient(API).Methods:Analysis was carried out with an Agilent ZORBAX Extend-C_(18)(150 mm×4.6 mm,5.0μm)column;the mobile phase was composed of acetonitrile-0.05%amnonia and 10 mmol·L^(-1)dodecyl trimethyl ammonium chloride in water(38∶62),with linear gradient elution at a flow rate of 1 mL·min^(-1).The detection wavelength was 288 nm.The column temperature was 25℃.Results:The linear range of the calibration curve for tetrahydrocurcumin was 0.149-7.452μg(r=0.9999).The average recovery was 99.9%(RSD=0.68%).Limits of quantity and detection were 0.011μg and 0.044μg,respectively.Tetrahydrocurcumin and its related substances were completely separated.According to this method,the contents of three batches of API were 98.6%,98.3%and 98.3%,respectively.Conclusion:Because of its simplicity,accuracy and specificity,this method is suitable for the determination of content of tetrahydrocurcumin API.

关 键 词：四氢姜黄素 高效液相色谱法 离子对试剂 含量测定 

分 类 号：R917[医药卫生—药物分析学]