| 基于HPLC法测定五氯柳胺阿苯达唑复方混悬液中的有关物质 |
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| 引用本文： | 李晓婷,白玉彬,李冰,董朕,孙继超,程富胜,张继瑜.基于HPLC法测定五氯柳胺阿苯达唑复方混悬液中的有关物质[J].中国畜牧兽医,2019,46(11):3422-3431. |
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| 作者姓名： | 李晓婷 白玉彬 李冰 董朕 孙继超 程富胜 张继瑜 |
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| 作者单位： | 1. 中国农业科学院兰州畜牧与兽药研究所, 农业农村部兽用药物创制重点实验室, 甘肃省新兽药工程重点实验室, 兰州 730050;2. 甘肃农业大学动物医学院, 兰州 730070 |
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| 基金项目： | "十二五"国家科技支撑计划项目（2015BAD11B01-01）；国家肉牛牦牛产业技术体系（CARS-37） |
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| 摘 要： | 试验旨在通过高效液相色谱（high performance liquid chromatography，HPLC）法测定五氯柳胺阿苯达唑复方混悬液的有关物质。采用高效液相色谱法，以自身对照法计算五氯柳胺阿苯达唑复方混悬液有关物质的量。选用Thermo Hypersil BDS C18色谱柱（4.6 mm×150 mm，5 μm）；流动相以0.1%磷酸-10 mmol/L磷酸二氢铵水溶液为A相，以甲醇为B相，31：69（V/V）；流速为1 mL/min；进样量为5 μL；柱温30℃；检测波长295 nm。结果显示，在建立的色谱条件下，五氯柳胺阿苯达唑复方混悬液中的主成分峰与杂质峰均能基线分离。3，5，6-三氯水杨酸、2-氨基-4，6-二氯苯酚盐酸盐、五氯柳胺、阿苯达唑在5~100 μg/mL内与峰面积线性关系良好（R2 ≥ 0.999），定量限分别为5 μg/mL及750、500、225 ng/mL，检测限分别为1 μg/mL及500、250、100 ng/mL，杂质3，5，6-三氯水杨酸、2-氨基-4，6-二氯苯酚盐酸盐总平均回收率分别为101.15%、100.35%，总平均回收率RSD均为0.71%（n=9）。经方法学验证，建立的HPLC方法简单、快速、准确，可用于五氯柳胺阿苯达唑复方混悬液中有关物质的测定。
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| 关 键 词： | 五氯柳胺 阿苯达唑 复方制剂 有关物质 高效液相色谱(HPLC) |
| 收稿时间： | 2019-03-14 |
Determination of Related Substances in Oxyclozanide and Albendazole Compound Suspension by HPLC |
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| LI Xiaoting,BAI Yubin,LI Bing,DONG Zhen,SUN Jichao,CHENG Fusheng,ZHANG Jiyu.Determination of Related Substances in Oxyclozanide and Albendazole Compound Suspension by HPLC[J].China Animal Husbandry & Veterinary Medicine,2019,46(11):3422-3431. |
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| Authors: | LI Xiaoting BAI Yubin LI Bing DONG Zhen SUN Jichao CHENG Fusheng ZHANG Jiyu |
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| Institution: | 1. Key Laboratory of Veterinary Pharmaceutical Development, Ministry of Agriculture and Rural Affairs, Key Laboratory of New Animal Drug Project of Gansu Province, Lanzhou Institute of Husbandry and Pharmaceutical Sciences, Chinese Academy of Agricultural Sciences, Lanzhou 730050, China;2. College of Veterinary Medicine, Gansu Agricultural University, Lanzhou 730070, China |
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| Abstract: | The purpose of experiment was established a high performance liquid chromatography (HPLC) method to determine the related substances of oxyclozanide and albendazole compound suspension.A HPLC was used to determine the related substances of oxyclozanide and albendazole in the compound suspension by self-contrast method.The chromatographic separeation was performed using a Thermo Hypersil BDS C18 column (4.6 mm×150 mm,5 μm) at 30℃.The mobile phase consisted of water containing 0.1% phosphoric acid and 10 mmol/L ammonium dihydrogen phosphate (A) and methanol (B) at a constant ratio of 31:69 (V/V) and a flow rate of 1 mL/min.The detection wavelength was 295 nm,and the injection volume was 5 μL.Under the above chromatographic conditions,the peaks of oxyclozanide,albendazole and impurity peaks could be completely separated.The good linear relationships for peak area for 3,5,6-trichlorosalicylic acid,2-amino-4,6-dichlorophenol hydrochloride,oxyclozanide and albendazole were obtained in the range of 5 to 100 μg/mL (R2 ≥ 0.999).LOQ were 5 μg/mL,750 ng/mL,500 ng/mL and 225 ng/mL,respectively.LOD were 1 μg/mL,500 ng/mL,250 ng/mL and 100 ng/mL,respectively.The average recovery of 3,5,6-trichlorosalicylic acid and 2-amino-4,6-dichlorophenol hydrochloride were 101.15% (RSD was 0.71%) and 100.35% (RSD was 0.71%),respectively.The validation results showed that the HPLC method was simple,rapid and accurate,and could be used to the related substances of oxyclozanide and albendazole compound suspension. |
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| Keywords: | oxyclozanide albendazole compound preparations related substances HPLC |
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