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<p>The present work describes a systematic application of quality by design (QbD) based strategy for developing and validating a high-performance thin layer chromatography (HPTLC) method for qualitative evaluation of bempedoic acid in bulk and its pharmaceutical tablet dosage form. Toluene: Ethyl acetate: acetonitrile: glacial acetic acid (5:3:2:0.1 v/v/v/v) were chosen as the mobile phase, and Merck HPTLC silica gel 60 F<sub>254</sub> plates as the stationary phase. Derivatization with anisaldehyde-sulfuric acid confirmed the presence of bempedoic acid, yielding a distinct R<sub>f</sub> value of 0.57 at 570&#xa0;nm scanning densitometric analysis.The calibration plot showed linearity in the180-900&#xa0;ng/spot range with a regression coefficient, r<sup>2</sup> of 0.996.Several critical analytical attributes (CAAs) were identified to assess the accuracy of the HPTLC technique performance. At the same time, the Box Behnken design (BBD) was used to optimize the critical method parameters (CMPs), including band length, band front, and saturation time. Optimization primarily emphasized the retardation factor as a vital analytical response. The proposed technique shows acceptable accuracy, precision, linearity, LOD, LOQ, and robustness according to the International Conference on Harmonization (ICH) guidelines. Acidic, basic, neutral, oxidative, and photolytic conditions were used in the degradation investigation. Hence, this study demonstrates the importance of AQbD in improving analytical method performance, providing a reliable and efficient HPTLC method. Additionally, the method’s greenness was evaluated using AGREE and GAPI tools, ensuring regulatory and environmental standards are met.</p>

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Stability indicating HPTLC method development and validation of bempedoic acid in bulk and tablet dosage form by using AQbD approach

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月27日

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  • Arun Maruti Kashid,
  • Vaishnavi Gopal Tupkar,
  • Aarti Satyanarayan Varma,
  • Aniket Dadaso Pawar

摘要

The present work describes a systematic application of quality by design (QbD) based strategy for developing and validating a high-performance thin layer chromatography (HPTLC) method for qualitative evaluation of bempedoic acid in bulk and its pharmaceutical tablet dosage form. Toluene: Ethyl acetate: acetonitrile: glacial acetic acid (5:3:2:0.1 v/v/v/v) were chosen as the mobile phase, and Merck HPTLC silica gel 60 F254 plates as the stationary phase. Derivatization with anisaldehyde-sulfuric acid confirmed the presence of bempedoic acid, yielding a distinct Rf value of 0.57 at 570 nm scanning densitometric analysis.The calibration plot showed linearity in the180-900 ng/spot range with a regression coefficient, r2 of 0.996.Several critical analytical attributes (CAAs) were identified to assess the accuracy of the HPTLC technique performance. At the same time, the Box Behnken design (BBD) was used to optimize the critical method parameters (CMPs), including band length, band front, and saturation time. Optimization primarily emphasized the retardation factor as a vital analytical response. The proposed technique shows acceptable accuracy, precision, linearity, LOD, LOQ, and robustness according to the International Conference on Harmonization (ICH) guidelines. Acidic, basic, neutral, oxidative, and photolytic conditions were used in the degradation investigation. Hence, this study demonstrates the importance of AQbD in improving analytical method performance, providing a reliable and efficient HPTLC method. Additionally, the method’s greenness was evaluated using AGREE and GAPI tools, ensuring regulatory and environmental standards are met.