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高效液相色谱法同时测定兽药复方酮康唑软膏中的酮康唑和甲硝唑含量
尹伶灵,杨志昆,周晶,商菲,张含侠,章安源,门晓冬,田成国,陈玲
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(山东省饲料兽药质量检验中心,山东省畜产品质量安全监测与风险评估重点实验室)
摘要:
建立了同时提取、测定兽药复方酮康唑软膏中酮康唑、甲硝唑含量的高效液相色谱(HPLC)法。采用C18色谱柱,甲醇-水为流动相,梯度洗脱,检测波长239nm。结果表明,酮康唑和甲硝唑2种成分线性关系良好(r > 0.999)。在3个不同浓度水平下酮康唑和甲硝唑平均加样回收率分别为 97.8% 和100.0%,溶液稳定性和方法重复性的RSD均小于1%。应用该方法测定3个不同厂家样品中2种组分的含量,结果符合要求。本方法简便,可靠,专属性强,重现性好,为该制剂的质量标准提高提供了研究基础。
关键词:  高效液相色谱法 兽药复方酮康唑软膏 酮康唑 甲硝唑
DOI:
投稿时间:2022-04-21修订日期:2022-08-23
基金项目:
Simultaneous determination of ketoconazole and metronidazole in compound ketoconazole ointment of veterinary drug by HPLC
(Shandong center for quality control of feed and veterinary drugs,Shandong Provincial Key Laboratory of Quality Safety Monitoring and Risk Assessment for Livestock and Poultry Products)
Abstract:
A method was developed for the simultaneous extraction and determination of Ketoconazole and Metronidazole in compound ketoconazole ointment of veterinary drug by High-performance liquid chromatography (HPLC). Chromatography was performed on C18 column at 239nm by the methanol-water as mobile phase, gradient elution. Analytical study showed that ketoconazole and metronidazole had a good linearity (r > 0.999). The average recovery rates of ketoconazole and metronidazole in three different concentrations were 97.8% and 100.0%, respectively. The RSD of the stability of the solution and the repeatability of the method were less than 1%. The method was applied to determine the contents of two components in samples from three different manufacturers, which results met the requirements. The method was simple, reliable, specific and reproducible, which provided the basis for the improvement of the quality standard of the preparation.
Key words:  HPLC  Compound ketoconazole ointment of veterinary drug  Ketoconazole  Metronidazole

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