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<p>The quality assurance of lipid nanoparticles (LNPs) is important for the effectiveness and safety of drugs. We developed a simple high-performance liquid chromatography (HPLC) method for rapid quality assessment of LNPs. LNPs prepared by a microchemical process were analyzed using a Tris gradient mobile phase and a poly-Lys–modified monolith as the stationary phase. This analysis produced two peaks at ~ 1 and 5&#xa0;min. The fractions were collected and examined for particle morphology and zeta potential. The 1-min peak contained 20–40&#xa0;nm nanoparticles, while the 5-min peak corresponded to LNPs. We applied this method to evaluate LNP stability after dilution with Tris buffer and exposure to 100 mM Ca²⁺. LNPs degraded within 1&#xa0;day in Ca²⁺ at 4&#xa0;°C, but &gt; 85% remained intact after 3 days in a 500-fold Tris buffer dilution. This method enables LNP analysis within 10&#xa0;min and provides a useful tool for LNP quality control.</p>

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Rapid quality evaluation of lipid nanoparticles using a monolithic HPLC column

  • 期刊论文

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  • 发表日期：

    2026年3月2日

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  • Shuhei Murayama,
  • Yukino Innami,
  • Yuki Nakatani,
  • Takashi Takaki,
  • Masatoshi Maeki,
  • Manabu Tokeshi,
  • Nozomi Murayama,
  • Masanori Motokawa,
  • Shota Miyazaki,
  • Eiichi Yamamoto,
  • Masaru Kato

摘要

The quality assurance of lipid nanoparticles (LNPs) is important for the effectiveness and safety of drugs. We developed a simple high-performance liquid chromatography (HPLC) method for rapid quality assessment of LNPs. LNPs prepared by a microchemical process were analyzed using a Tris gradient mobile phase and a poly-Lys–modified monolith as the stationary phase. This analysis produced two peaks at ~ 1 and 5 min. The fractions were collected and examined for particle morphology and zeta potential. The 1-min peak contained 20–40 nm nanoparticles, while the 5-min peak corresponded to LNPs. We applied this method to evaluate LNP stability after dilution with Tris buffer and exposure to 100 mM Ca²⁺. LNPs degraded within 1 day in Ca²⁺ at 4 °C, but > 85% remained intact after 3 days in a 500-fold Tris buffer dilution. This method enables LNP analysis within 10 min and provides a useful tool for LNP quality control.