胶束高效液相色谱法测定原料药、药品剂型、牛肝脏和牛肾脏中氟尼辛大聚胺的含量

Fathalla F. Belal , Sawsan A. Abd El-Razeq , Manal M. Fouad , Fatma A. Fouad
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引用次数: 11

摘要

建立了一种简便、灵敏、快速的液相色谱分析方法,并对原料药、制剂、牛肝脏和肾脏中氟尼辛- m的含量进行了验证。采用C18色谱柱,紫外检测波长284 nm,在4 min内完成分析分离。以0.15 M十二烷基硫酸钠、8%正丁醇和0.3%三乙胺为胶束溶液,以0.02 M磷酸为缓冲液,pH 7.0为流动相。该方法完全按照国际协调会议(ICH)指南进行了验证。检测限为0.02 μ mL−1,定量限为0.06 μ mL−1。加样回收率为95.58 ~ 106.94%。提取效率高,在提取过程中无基质干扰,在后续的色谱测定中无基质干扰。通过对验证参数的评价,该方法具有良好的重复性、线性和灵敏度。
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Micellar high performance liquid chromatographic determination of flunixin meglumine in bulk, pharmaceutical dosage forms, bovine liver and kidney

A simple, sensitive and rapid liquid chromatographic method was developed and validated for the analysis of flunixin meglumine (flunixin-M) in bulk, pharmaceutical dosage forms, bovine liver and kidney. Analytical separation was performed in less than 4 min using a C18 column with UV detection at 284 nm. A micellar solution composed of 0.15 M sodium dodecyl sulphate, 8% n-butanol and 0.3% triethylamine in 0.02 M phosphoric acid buffered at pH 7.0 was used as the mobile phase. The method was fully validated in accordance with the International Conference on Harmonization (ICH) guidelines. The limit of detection and the limit of quantitation were 0.02 and 0.06 μg mL−1, respectively. The recoveries obtained were in range of 95.58–106.94% for bovine liver and kidney. High extraction efficiency was obtained without matrix interference in the extraction process and in the subsequent chromatographic determination. The method showed good repeatability, linearity and sensitivity according to the evaluation of the validation parameters.

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