<abstract xmlns="http://www.w3.org/1999/xhtml">

<sec><h3>Objective</h3>
<p>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.</p>
</sec>
<sec>
<h3>Methods:</h3> <p>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.</p>
</sec>
<sec>
<h3>Result:</h3> <p>The verified validation parameters were: linearity, selectivity, specificity, precision (repeatability and reproducibility), robustness, limit of detection and quantification.</p>
</sec>
<sec>
<h3>Conclusions:</h3> <p>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.</p>
</sec>
</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.

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

Department of Pharmaceutical and Toxicological Chemistry

Scientific Center of Medicines “Nicolae Testemițanu” State University of Medicine and Pharmacy of the

Acta Marisiensis - Seria Medica

This work is licensed under the Creative Commons Attribution 4.0 International License.

Objective
The aim of current study was the development and validation of a reversed-phase high-pressure liquid chromatography (RPHPLC) method for the...

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

Published Online: Dec 28, 2023

Page range: 285 - 291

Received: Nov 07, 2023

Accepted: Dec 04, 2023

DOI: https://doi.org/10.2478/amma-2023-0049

Keywords
high pressure liquid chromatography, method validation, ear drops, isohydrafural, methyluracil

© 2023 Livia Uncu, published by Sciendo

This work is licensed under the Creative Commons Attribution 4.0 International License.

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

Published Online: Dec 28, 2023

Page range: 285 - 291

Received: Nov 07, 2023

Accepted: Dec 04, 2023

DOI: https://doi.org/10.2478/amma-2023-0049

Keywordshigh pressure liquid chromatography, method validation, ear drops, isohydrafural, methyluracil

© 2023 Livia Uncu, published by Sciendo

This work is licensed under the Creative Commons Attribution 4.0 International License.

Keywords
high pressure liquid chromatography, method validation, ear drops, isohydrafural, methyluracil