HPLC柱前衍生化法测定青霉胺片中的L-青霉胺  

Determination of L-penicillamine in Penicillamine tablets by Pre-column derivatization-HPLC

作　　者：李倚天 刘英[1] 李杨[1] LI Yitian;LIU Ying;LI Yang(Henan Provincial Institute of Food and Drug Control,Zhengzhou,Henan,450018 P.R.China)

机构地区：[1]河南省食品药品检验所,河南郑州450018

出　　处：《华西药学杂志》2022年第1期75-77,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用RP-HPLC柱前衍生化法测定青霉胺片中的对映异构体L-青霉胺。方法用茚三酮作为柱前衍生化试剂,考察流动相组成、检测器类型、衍生化条件等因素对检测结果的影响。结果1.902~6.182μg·mL^(-1)L-青霉胺与峰面积的线性关系良好(r=0.9994),检测限为12.56 ng,定量限为38.04 ng,平均回收率为98.0%(RSD=3.9%,n=9),方法的耐用性良好。结论所用方法简便、准确、快速,可用于检测青霉胺片中的对映异构体。OBJECTIVE To determine enantiomer L-penicillamine in Penicillamine tablets by Pre-column derivatization RP-HPLC.METHODS Separation of enantiomer was studied by using ninhydrin reagent as the pre-column derivatizing reagent.The effects of composition of the mobile phase,the type of the detector and the derivation condition were investigated.RESULTS The method was linear in the range of 1.902-6.182μg·mL^(-1)(r=0.9994),the limit of detection was 12.56 ng,and the limit of quantitation was 38.04 ng.The average recovery rate was 98.0%(RSD=3.9%,n=9).The ruggedness of the method was also verified.CONCLISION The method shows high sensitivity,convenience and good specificity,and can be applied for determine the enantiomer of Penicillamine tablets.

关 键 词：对映异构体 L-青霉胺 青霉胺片 茚三酮试剂 柱前衍生化 反相高效液相色谱法 重金属解毒药 质量评价 

分 类 号：R917[医药卫生—药物分析学]