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Purpose <p>This study aimed to develop a normal-phase&#xa0;TLC densitometry/ high-performance thin-layer chromatography (HPTLC) protocol, assisted with an&#xa0;Automatic Development Chamber 2 (ADC 2) for the efficient and robust pharmaceutical quantification of a thrombopoietin receptor agonist Eltrombopag Olamine (ELTO) using experimental design.</p> Methods <p>The effect of various factors on HPTLC outcomes has been studied using the Box-Behnken Design (BBD) to enhance method robustness. The ADC 2 was employed as an advancement in the development of a validated normal-phase HPTLC protocol, improving the method’s reproducibility and accuracy.</p> Results <p>TLC densitometry scans were performed at 399&#xa0;nm in reflectance mode optimizing the retention of ELTO at an R<sub><i>f</i></sub> value of 0.47 ± 0.02. The application of ADC 2 during the development minimized the impact of temperature and humidity. The BBD, supported with response surface methodology (RSM), was used to assess the method’s operable design region for increased robustness. The established linearity range was from 250 to 1500&#xa0;ng per spot, with a regression coefficient (<i>r</i><sup>2</sup>) of 0.9998. The developed protocol was validated according to Q2(R2) recommendations of the International Council for Harmonization (ICH).</p> Conclusion <p>NP-HPTLC is unique, efficient, precise, reproducible, and robust for the rapid quantification of ELTO. The method also uses minimal amount of organic solvents compared to well-known techniques such as high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS). The protocol is timesaving, allowing the simultaneous analysis of multiple samples, making it an effective alternative for determining ELTO in pharmaceutical formulations.</p> Graphical Abstract <p></p>

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Advanced Normal-Phase HPTLC Profiling of Eltrombopag Olamine with Automated Development and Box-Behnken Optimizations

  • 期刊论文

  • 发表日期：

    2025年1月7日

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  • Pranay M. Hadole,
  • Saurabh B. Ganorkar,
  • Suraj R. Chaudhari,
  • Vaishali N. Sonawane,
  • Preeti S. Bobade,
  • Amod S. Patil,
  • Atul A. Shirkhedkar

摘要

Purpose

This study aimed to develop a normal-phase TLC densitometry/ high-performance thin-layer chromatography (HPTLC) protocol, assisted with an Automatic Development Chamber 2 (ADC 2) for the efficient and robust pharmaceutical quantification of a thrombopoietin receptor agonist Eltrombopag Olamine (ELTO) using experimental design.

Methods

The effect of various factors on HPTLC outcomes has been studied using the Box-Behnken Design (BBD) to enhance method robustness. The ADC 2 was employed as an advancement in the development of a validated normal-phase HPTLC protocol, improving the method’s reproducibility and accuracy.

Results

TLC densitometry scans were performed at 399 nm in reflectance mode optimizing the retention of ELTO at an Rf value of 0.47 ± 0.02. The application of ADC 2 during the development minimized the impact of temperature and humidity. The BBD, supported with response surface methodology (RSM), was used to assess the method’s operable design region for increased robustness. The established linearity range was from 250 to 1500 ng per spot, with a regression coefficient (r2) of 0.9998. The developed protocol was validated according to Q2(R2) recommendations of the International Council for Harmonization (ICH).

Conclusion

NP-HPTLC is unique, efficient, precise, reproducible, and robust for the rapid quantification of ELTO. The method also uses minimal amount of organic solvents compared to well-known techniques such as high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS). The protocol is timesaving, allowing the simultaneous analysis of multiple samples, making it an effective alternative for determining ELTO in pharmaceutical formulations.

Graphical Abstract