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<p>Parkinson’s disease is a progressive neurodegenerative disorder with an increasing global prevalence, necessitating advanced therapeutic and analytical approaches. Puerarin, a phytoconstituent from <i>Pueraria lobata</i> (Kudzu), has therapeutic potential in respiratory illnesses, neurological diseases, psoriasis, and viral infections. However, puerarin quantification remains challenging due to complex methods, prolonged retention times, and missing stability-indicating degradation studies in published data. This study develops a simple, reliable, rapid, and cost-effective reverse-phase high-performance liquid chromatography method for quantifying puerarin in marketed and nanoformulations. A central composite design enabled statistical optimization, fewer experimental runs, and critical analytical attributes. The method was validated as per ICH (Q2R1) guidelines. Chromatographic conditions included an acetic acid buffer (0.1%, pH 3.2):methanol (50:50, v/v) mobile phase, a 1&#xa0;mL&#xa0;min<sup>−1</sup> flow rate and a 250&#xa0;nm detection wavelength, achieving a puerarin retention time of 3.1&#xa0;min. The linear calibration curve (<i>R</i><sup>2</sup> &gt; 0.999) had LOD and LOQ values of 0.2148&#xa0;µg&#xa0;mL<sup>−1</sup> and 0.6511&#xa0;µg&#xa0;mL<sup>−1</sup>, respectively. Precision studies (intra-day and inter-day) showed an RSD below 2% with consistent recovery. The method quantified puerarin in marketed and nanoformulations with 102.29% and 98.84% efficiency. Stress degradation studies confirmed robustness. The developed method provides a reasonably lower retention time and its validation produces quality data compared with publications resembling a problem-solving approach for quantifying puerarin. This validated method provides an accurate, precise, and economical strategy for puerarin quantification in pharmaceuticals.</p>

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Quality-by-Design-Driven Stability-Indicating Reverse-Phase High-Performance Liquid Chromatographic Method for Puerarin Quantification in Marketed Formulation and Lipid–Polymer Nanoparticles

  • 期刊论文

  • 发表日期：

    2025年8月21日

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  • Shivaraj Hooli,
  • Kishori P. Sutar,
  • Sankalp S. Sammasagi,
  • Mahendra Kumar Chouhan

摘要

Parkinson’s disease is a progressive neurodegenerative disorder with an increasing global prevalence, necessitating advanced therapeutic and analytical approaches. Puerarin, a phytoconstituent from Pueraria lobata (Kudzu), has therapeutic potential in respiratory illnesses, neurological diseases, psoriasis, and viral infections. However, puerarin quantification remains challenging due to complex methods, prolonged retention times, and missing stability-indicating degradation studies in published data. This study develops a simple, reliable, rapid, and cost-effective reverse-phase high-performance liquid chromatography method for quantifying puerarin in marketed and nanoformulations. A central composite design enabled statistical optimization, fewer experimental runs, and critical analytical attributes. The method was validated as per ICH (Q2R1) guidelines. Chromatographic conditions included an acetic acid buffer (0.1%, pH 3.2):methanol (50:50, v/v) mobile phase, a 1 mL min−1 flow rate and a 250 nm detection wavelength, achieving a puerarin retention time of 3.1 min. The linear calibration curve (R2 > 0.999) had LOD and LOQ values of 0.2148 µg mL−1 and 0.6511 µg mL−1, respectively. Precision studies (intra-day and inter-day) showed an RSD below 2% with consistent recovery. The method quantified puerarin in marketed and nanoformulations with 102.29% and 98.84% efficiency. Stress degradation studies confirmed robustness. The developed method provides a reasonably lower retention time and its validation produces quality data compared with publications resembling a problem-solving approach for quantifying puerarin. This validated method provides an accurate, precise, and economical strategy for puerarin quantification in pharmaceuticals.