摘要
为了测定五氯柳胺混悬液的含量和有关物质,建立了一种高效液相色谱法(HPLC)。含量测定方法采用Hypersil BDS C18(150 mm×4. 6 mm,5μm)色谱柱,流动相为0. 1%磷酸水-甲醇(体积比为38∶62),检测波长为300 nm,柱温为25℃。有关物质测定方法采用Inert Sustain Swift C18(150 mm×4. 0 mm,5μm)色谱柱,流动相、检测波长、柱温与含量测定方法相同。结果表明,五氯柳胺混悬液检测质量浓度线性范围为34. 01～104. 35μg·m L^(-1)(R^2=1. 000),平均回收率为100. 1%;已知杂质2-氨基-4,6-二氯苯酚盐酸盐和3,5,6-三氯水杨酸线性范围为0. 51～20. 4μg·m L^(-1)(R^2分别为0. 996、1. 000),平均回收率分别为110. 3%和98. 6%。本研究建立的方法方便、简单、准确,可同时测定五氯柳胺混悬液的含量及有关物质,为该产品的质量控制提供标准。
In order to detect the content and related substances of oxyclozanide suspension,a new method using high performance liquid chromatography (HPLC) was established.Content determination was carried out using Hypersil BDS C18 (150 mm×4.6 mm,5 μm) column and 0.1% phosphoric acid water-method (volume ratio=38∶62) as mobile phase,column temperature was 25 ℃,and determination wavelength was 300 nm.Related substances was carried out using InertSustainSwift C18 (150 mm×4.0 mm,5μm) column,mobile phase,detection wavelength and column temperature were the same as the content determination method.The results showed that liner range of content determination of oxyclozanide suspension were 34.01-104.35 μg ·mL^-1 (R^2=1.000),and average recovery was 100.1%.The liner range of 2-amino-4,6-dichlorophenol hydrochloride and 3,5,6-trichlorosalicylic acid were 0.51-20.4 μg ·mL^-1 (R^2=0.996,1.000,respectively),and average recovery were 110.3% and 98.6%,respectively.It showed that the method was convenient,simple and accurate,and could simultaneously determine the content and related substances of oxyclozanide suspension,and provided standards for quality control of the product.
作者
白玉彬
张吉丽
朱建民
苏文杰
董朕
周绪正
张继瑜
BAI Yubin;ZHANG Jili;ZHU Jianmin;SU Wenjie;DONG Zhen;ZHOU Xuzheng;ZHANG Jiyu(Lanzhou Institute of Husbandry and Pharmaceutical Science,Chinese Academy of Agricultural Sciences,Lanzhou 730050,China;Changzhou Yabang-QH Pharmachem Co.,Ltd.,Changzhou 213000,China)
出处
《浙江农业学报》
CSCD
北大核心
2019年第2期268-278,共11页
Acta Agriculturae Zhejiangensis
基金
国家科技支撑计划(2015BAD11B01-01)
国家肉牛牦牛产业技术体系药物开发与临床用药岗位(CARS-37)
