5种解热镇痛药中违规添加马来酸氯苯那敏的HPLC-PDA检测方法研究OA
Determination of chlorphenairmine maleate illegal adulterated into 5 antipyretic analgesics by HPLC-PDA
建立了5种解热镇痛药中违规添加马来酸氯苯那敏的HPLC-PDA检测方法.采用Eicoee WT C18色谱柱(4.6 mm×150.0 mm,5µm);流动相为0.02 mol/L庚烷磺酸钠溶液(含1%三乙胺,用磷酸调节pH值至5.5)-乙腈(体积比为70∶30);流速为1.0 mL/min;光电二极管阵列检测器(Waters 2998,PDA),扫描范围为200~400 nm,检测波长为260 nm,柱温为30℃,进样体积10µL.结果显示,马来酸氯苯那敏的线性范围为0.052~41.500µg/mL(r=0.999 97),安乃近注射液、氨基比林注射液、安痛定注射液、对乙酰氨基酚注射液、双氯酚酸钠注射液回收率分别为100.7%(RSD=0.9%)、98.1%(RSD=0.6%)、98.6%(RSD=0.4%)、97.8%(RSD=0.9%)、99.1%(RSD=0.6%).该方法分离度良好、灵敏度高、简便准确,可用于常见解热镇痛注射液中违规添加马来酸氯苯那敏的含量检测.
The objective was to establish a method for the detection of illegal addition of chlorpheniramine maleate in 5 kinds of antipyretic analgesics.Eicoee WT C18(4.6 mm×150.0 mm,5µm)was used.The mobile phase was 0.02 mol/L sodium heptanesulfonate solution(containing 1%triethylamine,adjusted to pH 5.5 with phosphoric acid)-acetonitrile(70∶30,V∶V);the flow rate was 1.0 mL/min.PDA detector,scanning range of 200-400 nm,detection wavelength was 260 nm,column temperature was 30℃,and the injection volume was 10µL.The linear range of chlorphenamine maleate was 0.052-41.500 µg/mL(r=0.999 97).The average recoveries of analgin injection,aminopyrine injection,antonidine injection,paracetamol injection and diclofenac sodium injection were 100.7%(RSD=0.9%),98.1%(RSD=0.6%),98.6%(RSD=0.4%),97.8%(RSD=0.9%)and 99.1%(RSD=0.6%),respectively.The method has good resolution,high sensitivity,simplicity and accuracy,and can be used for the detection of the content of chlorpheniramine maleate illegally added in common antipyretic analgesic injection.
邱天宝;贾楠楠;刘占通;朱雷;董鹏;李慧素;赵富华
河南省农畜水产品检验技术研究院,河南 郑州 450008河南省农畜水产品检验技术研究院,河南 郑州 450008河南省农畜水产品检验技术研究院,河南 郑州 450008河南省农畜水产品检验技术研究院,河南 郑州 450008河南省农畜水产品检验技术研究院,河南 郑州 450008河南省农畜水产品检验技术研究院,河南 郑州 450008中国兽医药品监察所,北京 100081
农业科技
马来酸氯苯那敏解热镇痛药非法添加HPLC
chlorpheniramine maleateantipyretic analgesicsillegal additionHPLC
《中兽医医药杂志》 2026 (2)
57-62,6
河南省市场监督管理局科技计划项目(HNKE2025031314860027034145)
评论