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Introduction <p>A common selective serotonin reuptake inhibitor used to treat depression and obsessive–compulsive disorder is fluvoxamine maleate. </p> Objective <p>The goal of this study was to develop and validate a HPTLC method for the analysis of fluvoxamine maleate in pharmaceutical dosage forms, utilizing a risk-based quality by design approach.</p> Methods <p>HPTLC method was optimized with a mobile phase composed of toluene: ethyl acetate: methanol: triethylamine in a ratio of 1: 5: 4: 0.1 (v/v/v/v). UV detection was performed at 257&#xa0;nm. Studies on forced degradation were carried out in a variety of stress environments, including as thermal, oxidative, hydrolytic, alkaline, acidic, and photolytic conditions, to assess stability of fluvoxamine maleate. The degradation products were characterized using high-resolution mass spectrometry to identify potential impurities and degradation pathways.</p> Results <p>The developed method demonstrated excellent linearity over a concentration range of 100 to 600&#xa0;ng/band, with a correlation coefficient of 0.9994 and the LOD and LOQ values were found to be 15.36&#xa0;ng/band and 46.55&#xa0;ng/band. The method was validated in accordance with ICH Q2(R1) guidelines, confirming its specificity, linearity, precision, accuracy, and robustness. The green chemistry aspects of the method were evaluated using Analytical Greenness Metric Approach and Software and Green Analytical Procedure Index, which highlighted the method’s eco-friendly characteristics. Additionally, the Blue Applicability Grade Index tool was used to assess the method’s practicality and suitability for routine pharmaceutical analysis, confirming its application in real-world settings.</p> Conclusion <p>The validated HPTLC method for analyzing fluvoxamine maleate in tablet dosage forms was robust, reliable, and accurate. It effectively identified and characterized degradation products, ensuring the consistent quality and safety of pharmaceutical products. The method offers a sustainable and efficient alternative for quality control in the pharmaceutical industry, combining rigorous validation with environmentally conscious practices.</p> Graphical Abstract <p></p>

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A Quality-Driven, Eco-friendly High-Performance Thin-Layer Chromatography Method for Fluvoxamine Maleate Analysis in Tablets and MS Identification of its Degradation Products

  • 期刊论文

  • 发表日期：

    2025年6月19日

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  • Vidhya K. Bhusari,
  • Prasad S. Giri,
  • Minal R. Ghante

摘要

Introduction

A common selective serotonin reuptake inhibitor used to treat depression and obsessive–compulsive disorder is fluvoxamine maleate.

Objective

The goal of this study was to develop and validate a HPTLC method for the analysis of fluvoxamine maleate in pharmaceutical dosage forms, utilizing a risk-based quality by design approach.

Methods

HPTLC method was optimized with a mobile phase composed of toluene: ethyl acetate: methanol: triethylamine in a ratio of 1: 5: 4: 0.1 (v/v/v/v). UV detection was performed at 257 nm. Studies on forced degradation were carried out in a variety of stress environments, including as thermal, oxidative, hydrolytic, alkaline, acidic, and photolytic conditions, to assess stability of fluvoxamine maleate. The degradation products were characterized using high-resolution mass spectrometry to identify potential impurities and degradation pathways.

Results

The developed method demonstrated excellent linearity over a concentration range of 100 to 600 ng/band, with a correlation coefficient of 0.9994 and the LOD and LOQ values were found to be 15.36 ng/band and 46.55 ng/band. The method was validated in accordance with ICH Q2(R1) guidelines, confirming its specificity, linearity, precision, accuracy, and robustness. The green chemistry aspects of the method were evaluated using Analytical Greenness Metric Approach and Software and Green Analytical Procedure Index, which highlighted the method’s eco-friendly characteristics. Additionally, the Blue Applicability Grade Index tool was used to assess the method’s practicality and suitability for routine pharmaceutical analysis, confirming its application in real-world settings.

Conclusion

The validated HPTLC method for analyzing fluvoxamine maleate in tablet dosage forms was robust, reliable, and accurate. It effectively identified and characterized degradation products, ensuring the consistent quality and safety of pharmaceutical products. The method offers a sustainable and efficient alternative for quality control in the pharmaceutical industry, combining rigorous validation with environmentally conscious practices.

Graphical Abstract