中国兽药杂志2026,Vol.60Issue(8):53-59,7.DOI:10.11751/ISSN.1002-1280.2026.8.10
恩诺沙星片溶出度测定方法的建立
Establishment of Dissolution Test Method of Enrofloxacin Tablets
徐丽佳 1李欣南 1韩春晓 1许彬 1高红倩 1李妍 1刘骐玮 2田晓玲1
作者信息
- 1. 辽宁省检验检测认证中心(辽宁省农产品及兽药饲料产品检验检测院),沈阳 110036
- 2. 沈阳药科大学药学院,辽宁本溪 117004
- 折叠
摘要
Abstract
To establish a dissolution testing method for enrofloxacin tablets.Dissolution tests were conducted using the paddle method with citric acid buffer as the dissolution medium;the rotation speed was set at 75 r/min,the dissolution time was 30 min;the chromatographic column was Waters C18(250 mm ×4.6 mm,5.0 μm);the mobile phase was a phosphate solution(0.025 mol/L,adjusted to pH 3.0 with triethylamine)-acetonitrile(83∶17);the flow rate was 1.0 mL/min;the column temperature was 35 ℃;the detection wavelength was 278 nm;the injection volume was 10 μL.The dissolution of enrofloxacin tablets was determined by high-performance liquid chromatography,and methodological validation was performed.Within the range of 1.25~50 μg/mL,enrofloxacin concentration exhibited a good linear relationship with peak area.At 75 r/min and 30 min,all samples showed an inflection point in the dissolution curve,entering a plateau phase,with dissolution degrees exceeding 75%of the labeled amount.The established method is simple to operate,highly sensitive,and reproducible,effectively ensuring product quality and efficacy.关键词
恩诺沙星片/溶出度/高效液相色谱法Key words
Enrofloxacin tablets/dissolution/HPLC分类
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徐丽佳,李欣南,韩春晓,许彬,高红倩,李妍,刘骐玮,田晓玲..恩诺沙星片溶出度测定方法的建立[J].中国兽药杂志,2026,60(8):53-59,7.