用高效液相色谱法测定滴耳液中的异水杨醛和甲基尿嘧啶

Q4 Pharmacology, Toxicology and Pharmaceutics

Acta Marisiensis - Seria Medica Pub Date : 2023-12-01 DOI:10.2478/amma-2023-0049

Livia Uncu

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引用次数: 0

摘要

摘要目的建立并验证一种反相高压液相色谱法（RPHPLC），用于定量测定固定剂量复方滴耳液中的两种活性成分--异氢糠醛（IHF）和甲基尿嘧啶（MU）。方法：采用 Teknokroma C1 5μm (150*4,6mm)色谱柱，甲醇：水 60:40（V：V）流动相，柱温 300℃，流速 0.6 mL/min，实现了两种化合物的高效分离。总分析时间为 5.5 分钟。结果验证参数包括：线性、选择性、特异性、精密度（重复性和再现性）、稳健性、检出限和定量。结论该方法分离效果好，无其他色谱峰干扰，分析时间短。新开发的色谱法可用于分析异氢呋喃和甲基尿嘧啶的固定剂量复合滴耳剂。

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Determination of isohydrafural and methyluracil in ear drops by high performance liquid chromatography

Abstract Objective The aim of current study was the development and validation of a reversed-phase high-pressure liquid chromatography (RPHPLC) method for the quantitative determination of two active ingredients, isohydrafural (IHF) and methyluracil (MU) in fixed dose combination ear drops. Methods: An efficient separation of the two compounds was achieved on a Teknokroma C1 5μm (150*4,6mm) column, with a methanol: water 60:40 (V: V) mobile phase, at 300C temperature and 0.6 mL/min flow-rate. The total analysis time was 5.5 min. Result: The verified validation parameters were: linearity, selectivity, specificity, precision (repeatability and reproducibility), robustness, limit of detection and quantification. Conclusions: Good separation and lack of interference from other chromatographic peaks, rapidanalysis times were obtained. The newly developed chromatographic method can be applied for the analysis of fixed dose combination ear drops with isohydrafural and methyluracil.

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来源期刊

Acta Marisiensis - Seria Medica Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)

CiteScore

0.40

自引率

0.00%

发文量

审稿时长

24 weeks