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Purpose <p>The goal of this study is to develop a High-Performance Thin Layer Chromatography method for baricitinib determination, which lowers the cost of analysis. Based on the literature survey, no previously published HPTLC method has been reported for the analysis of baricitinib, which encouraged the development of an HPTLC method with an environmentally friendly approach.</p> Method <p>A precoated TLC plate uses silica gel 60 F254 as the stationary phase, which is run in a mobile phase of ethyl acetate, toluene, and methanol in a ratio of 5:3.5:1.5 (v/v). Densitometric analysis was conducted at 310&#xa0;nm in an absorbance mode. According to ICH Q2(R2) criteria, the developed method was validated. Stability was performed as per ICH guidelines Q1A(R2) and Q1B, which includes acid, alkaline, oxidation, neutral, thermal, and photolytic stress conditions.</p> Results <p>The Rf value of baricitinib was found to be 0.498 ± 0.037. The linearity range lies between 300 and 900 ng/band with a correlation coefficient of 0.9958. The developed method has been successfully applied to tablet formulation, with excellent recoveries ranging from 98.11% to 102%. The % content of the baricitinib tablet was found to be 98.2-100.35%. Baricitinib shows excellent sensitivity, with a limit of detection of 50 ng/band and a limit of quantitation of 153 ng/band. Stability was found to be more susceptible to alkaline degradation. Based on the greenness assessment tools, the analytical eco-score of 76 and the pictograms for GAPI, AGREE, and AGREE prep indicated the method’s greenness. The multi-color assessment (MA) tool further confirmed high sustainability (GEMAM 95.2%), excellent practicality (BAGI 90%), superior analytical performance (RAPI 87.5%) and good innovation (VIGI 60%). The final whiteness score is 83.2% with excellent score.</p> Conclusion <p>The developed method exhibited excellent greenness. A sensitive, precise, rapid, simple, and robust HPTLC method has been proposed and validated for determining the amount of baricitinib in API and pharmaceutical formulation and can be successfully applied for the routine quantitative analysis.</p>

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Development of Stability-Indicating Green HPTLC Method for Quantitative Analysis of Baricitinib in API and Pharmaceutical Formulation

  • 期刊论文

  • 发表日期：

    2026年2月27日

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  • Rina Ikhar,
  • Himanshi Bele,
  • Prafulla Sabale,
  • Amol Warokar,
  • Vidya Sabale

摘要

Purpose

The goal of this study is to develop a High-Performance Thin Layer Chromatography method for baricitinib determination, which lowers the cost of analysis. Based on the literature survey, no previously published HPTLC method has been reported for the analysis of baricitinib, which encouraged the development of an HPTLC method with an environmentally friendly approach.

Method

A precoated TLC plate uses silica gel 60 F254 as the stationary phase, which is run in a mobile phase of ethyl acetate, toluene, and methanol in a ratio of 5:3.5:1.5 (v/v). Densitometric analysis was conducted at 310 nm in an absorbance mode. According to ICH Q2(R2) criteria, the developed method was validated. Stability was performed as per ICH guidelines Q1A(R2) and Q1B, which includes acid, alkaline, oxidation, neutral, thermal, and photolytic stress conditions.

Results

The Rf value of baricitinib was found to be 0.498 ± 0.037. The linearity range lies between 300 and 900 ng/band with a correlation coefficient of 0.9958. The developed method has been successfully applied to tablet formulation, with excellent recoveries ranging from 98.11% to 102%. The % content of the baricitinib tablet was found to be 98.2-100.35%. Baricitinib shows excellent sensitivity, with a limit of detection of 50 ng/band and a limit of quantitation of 153 ng/band. Stability was found to be more susceptible to alkaline degradation. Based on the greenness assessment tools, the analytical eco-score of 76 and the pictograms for GAPI, AGREE, and AGREE prep indicated the method’s greenness. The multi-color assessment (MA) tool further confirmed high sustainability (GEMAM 95.2%), excellent practicality (BAGI 90%), superior analytical performance (RAPI 87.5%) and good innovation (VIGI 60%). The final whiteness score is 83.2% with excellent score.

Conclusion

The developed method exhibited excellent greenness. A sensitive, precise, rapid, simple, and robust HPTLC method has been proposed and validated for determining the amount of baricitinib in API and pharmaceutical formulation and can be successfully applied for the routine quantitative analysis.