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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

Determination of chlorphenairmine maleate illegal adulterated into 5 antipyretic analgesics by HPLC-PDA

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【作者】 邱天宝贾楠楠刘占通朱雷董鹏李慧素赵富华

【Author】 QIU Tianbao;JIA Nannan;LIU Zhantong;ZHU Lei;DONG Peng;LI Huisu;ZHAO Fuhua;Henan Academy of Agricultural, Livestock and Aquatic Products Inspection Technology;China Institution of Veterinary Drug Control;

【通讯作者】 赵富华;

【机构】 河南省农畜水产品检验技术研究院中国兽医药品监察所

【摘要】 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,5??m);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10??L。结果显示,马来酸氯苯那敏的线性范围为0.052~41.500??g/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。

【Abstract】 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, 5 ??m) 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 10 ??L. The linear range of chlorphenamine maleate was 0.052-41.500 ??g/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.

【基金】 河南省市场监督管理局科技计划项目(HNKE2025031314860027034145)
  • 【文献出处】 中兽医医药杂志 ,Journal of Traditional Chinese Veterinary Medicine , 编辑部邮箱 ,2026年02期
  • 【分类号】S859
  • 【下载频次】34
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