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<p>A systematic Analytical Quality by Design based reverse-phase high-performance liquid chromatography method was successfully developed and validated for the quantification of Landiolol in pharmaceutical formulations. The method optimization employed Central Composite Design with Analysis of Variance revealing a statistically significant model (F-value = 11.60, <i>p</i> = 0.0003). The optimized chromatographic conditions included an Inertsil ODS column (150 × 4.6&#xa0;mm, 5&#xa0;μm), mobile phase comprising 55% sodium dihydrogen phosphate and 0.2% orthophosphoric acid, flow rate of 1.25 mL/min, injection volume of 15 µL, and detection wavelength of 240&#xa0;nm, yielding a retention time of 2.70&#xa0;min. The validated method demonstrated excellent system suitability with USP tailing factor of 1.0, plate count of 10,925, and similarity factor of 98.4%. System precision showed exceptional reproducibility with %RSD of 0.3%, while linearity was established over the concentration range with R² = 0.9999. Accuracy studies revealed recoveries between 100.8 and 101.1% across 50%, 100%, and 150% levels. Forced degradation studies indicated Landiolol stability under thermal (3% degradation) and oxidative conditions (4% degradation) but significant photolytic degradation (9%). The greenness assessment yielded a score of 0.88, confirming environmental sustainability. This robust, precise, and environmentally conscious analytical method complies with regulatory guidelines for routine quality control and pharmaceutical analysis of Landiolol formulations.</p> Graphical Abstract <p></p>

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Development and validation of a robust RP-HPLC method for Landiolol using analytical quality by design

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月31日

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  • S. Harshini,
  • Panneerselvam Theivendren,
  • Saravanan Govindaraj

摘要

A systematic Analytical Quality by Design based reverse-phase high-performance liquid chromatography method was successfully developed and validated for the quantification of Landiolol in pharmaceutical formulations. The method optimization employed Central Composite Design with Analysis of Variance revealing a statistically significant model (F-value = 11.60, p = 0.0003). The optimized chromatographic conditions included an Inertsil ODS column (150 × 4.6 mm, 5 μm), mobile phase comprising 55% sodium dihydrogen phosphate and 0.2% orthophosphoric acid, flow rate of 1.25 mL/min, injection volume of 15 µL, and detection wavelength of 240 nm, yielding a retention time of 2.70 min. The validated method demonstrated excellent system suitability with USP tailing factor of 1.0, plate count of 10,925, and similarity factor of 98.4%. System precision showed exceptional reproducibility with %RSD of 0.3%, while linearity was established over the concentration range with R² = 0.9999. Accuracy studies revealed recoveries between 100.8 and 101.1% across 50%, 100%, and 150% levels. Forced degradation studies indicated Landiolol stability under thermal (3% degradation) and oxidative conditions (4% degradation) but significant photolytic degradation (9%). The greenness assessment yielded a score of 0.88, confirming environmental sustainability. This robust, precise, and environmentally conscious analytical method complies with regulatory guidelines for routine quality control and pharmaceutical analysis of Landiolol formulations.

Graphical Abstract