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兽药中非法添加8种解热镇痛类药物HPLC-PDA检测方法的建立
马秋冉,赵富华,王雷,杨星,于晓辉
0
(中国兽医药品监察所)
摘要:
建立了20种兽药制剂中非法添加对乙酰氨基酚、水杨酸、安乃近、安替比林、氨基比林、萘普生、双氯芬酸钠、吲哚美辛等8种解热镇痛类药物的HPLC-PDA检测方法。采用十八烷基键合硅胶为填充剂;以磷酸盐缓冲液-甲醇-乙腈为流动相,梯度洗脱,流速1.0 mL/min;二极管阵列检测器,波长为229 nm。通过液相色谱保留时间、峰纯度检查和光谱相似度检查对非法添加物进行确证。结果表明,该色谱条件下,8种解热镇痛类药物间分离度良好,检测限为0.4~2.5 g/kg(L),回收率在94.4%~103.7%之间,RSD≤1.9%。该方法快速简便、准确可靠、灵敏度高,适用于兽药制剂中8种解热镇痛类药物的同时快速检测。
关键词:  高效液相色谱法  兽药制剂  非法添加  解热镇痛类药物
DOI:
投稿时间:2023-12-21修订日期:2024-11-06
基金项目:“十四五”国家重点研发计划项目(YFD1801105);中国兽医药品监察所兽药行业公益性重点专项(NO.GY2021007)
Determination of 8 Kinds of Antipyretics and Analgesics Drugs Illegally Added in Veterinary Drugs by HPLC-PDA
(China Institute of Veterinary Drug Control,Beijing,100081;China)
Abstract:
A method was established for the determination of eight kinds of antipyretics and analgesics drugs in veterinary drugs by the high-perofrmance liquid chromatography with photo-diode detector (HPLC-PAD). C18 column was applied with mobile phase consisting of phosphate buffer-methanol-acetonitrile, gradient elution, at a flow of 1.0 mL/min. The detection wavelength was 229 nm. Retention time, peak purity test and spectrum similar test was utilized to identify the antipyretics and analgesics drugs. Eight kinds of antipyretics and analgesics drugs were detected through the established method which showed a good limits of detection in the range of 0.4~2.5 g/kg(L). The average recoveries ranged from 94.4%~103.7%, and RSD were less than 1.9%. The study indicates that the proposed method is efficient, reliable and sensitive, which can be used for the simultaneous determination of 8 kinds of antipyretics and analgesics drugs in veterinary drugs.
Key words:  high performance liquid chromatography  veterinary drugs  illegally addition  antipyretics and analgesics drugs

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