HPLC法同时测定复方岩白菜素片中岩白菜素和马来酸氯苯那敏的含量  

Simultaneous Determination of Bergenin and Chlorpheniramine Maleate in Compound Petroselin Tablets by HPLC Method

作　　者：张李莉 蒋晓蕊 张玉 贾新征 周凤盈 范桂强 ZHANG Lili;JIANG Xiaorui;ZHANG Yu;JIA Xinzheng;ZHOU Fengying;FAN Guiqiang(Hengshui Comprehensive Inspection and Testing Center,Hebei Hengshui 053000;Hengshui Institute of Quality and Standardization,Hebei Hengshui 053000;Hengshui Adverse Drug Reaction Monitoring Center,Hebei Hengshui 053000,China)

机构地区：[1]衡水市综合检验检测中心,河北衡水053000 [2]衡水市质量和标准化研究院,河北衡水053000 [3]衡水市药品不良反应监测中心,河北衡水053000

出　　处：《广州化工》2025年第3期74-78,共5页GuangZhou Chemical Industry

基　　金：河北省药品监督管理局科技计划项目(No:2023ZC1033)。

摘　　要：建立高检测灵敏度的高效液相色谱法同时测定复方岩白菜素片中岩白菜素和马来酸氯苯那敏两种有效成分的含量。色谱柱为Z0RBAX SB-C^(18)柱(4.6×250 mm,5μm);流动相为甲醇-水(含三乙胺0.5%,用磷酸调节pH值至2.5)(40∶60);流速为1.0 mL/min;柱温为30℃;检测波长(0~8 min在243 nm波长下检测岩白菜素,8~18 min在222 nm波长下检测马来酸氯苯那敏)。2个有效成分的线性范围分别为岩白菜素100~2500μg/mL(r=0.9999)、马来酸氯苯那敏10~200μg/mL(r=0.9999),岩白菜素加样回收率为99.63%、99.98%、99.27%、99.06%、98.75%、98.99%,RSD为0.46%(n=6);马来酸氯苯那敏加样回收率为103.23%、103.24%、104.69%、104.26%、、102.91%、103.07%,RSD为0.77%(n=6)。该方法简便、准确、灵敏度高、重复性好,可用于复方岩白菜素片中岩白菜素和马来酸氯苯那敏两个有效成分的定量测定。A high performance liquid chromatographic(HPLC)method with high detection sensitivity was established for the simultaneous determination of two active ingredients,namely,bergenin and chlorpheniramine maleate,in Compound Petroselin Tablets.The chromatographic column was a Z0RBAX SB-C_(18)column(4.6×250 mm,5μm),and the mobile phase was methanol-water(containing 0.5%triethylamine,pH adjusted to 2.5 with phosphoric acid)(40∶60)at a flow rate of 1.0 mL/min,with the column temperature at 30℃.The linear ranges of the two active ingredients were 100~2500μg/mL for bergenin(r=0.9999)and 10~200μg/mL for chlorpheniramine maleate(r=0.9999),and the recoveries of bergenin were 99.63%,99.98%,99.27%,99.06%,99.98%,98.75%,98.99%,99.97%and 99.06%,respectively,98.75%,98.99%,with an RSD of 0.46%(n=6);and the spiked recoveries of chlorpheniramine maleate were 103.23%,103.24%,104.69%,104.26%,102.91%,103.07%,with an RSD of 0.77%(n=6).The method is simple,accurate,highly sensitive and reproducible,and can be used for the quantitative determination of the two active ingredients,bergenin and chlorpheniramine maleate,in compound petroselin tablets.

关 键 词：高效液相色谱法 同时测定 含量测定 岩白菜素 马来酸氯苯那敏 

分 类 号：R917[医药卫生—药物分析学]