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<p>A simple, robust, and reproducible reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative determination and stability assessment of Remdesivir. Forced degradation studies were conducted under acidic, alkaline, oxidative, thermal, and photolytic conditions to evaluate the intrinsic stability of the drug. Chromatographic separation was achieved on an Eclipse Plus C18 column (150 × 4.6&#xa0;mm, 5&#xa0;μm) using a gradient elution of 0.1% formic acid in water (mobile phase A) and acetonitrile (mobile phase B) at a flow rate of 1.0 mL/min. Detection was performed at 245&#xa0;nm using a diode array detector. The method demonstrated excellent linearity over the concentration range of 2–40&#xa0;µg/mL, with recovery between 98.78% and 102.05%. Validation parameters complied with ICH Q2(R1) guidelines. Degradation products generated under acidic, alkaline, and oxidative conditions were further Identified using liquid chromatography–tandem mass spectrometry (LC–MS/MS). Based on the m/z values of the degradants, probable degradation pathways were proposed. The method was successfully applied for the quantitative estimation of Remdesivir in bulk drug and injectable formulations, confirming its utility as a stability-indicating analytical tool.</p>

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Novel stability-indicating RP-HPLC method for remdesivir with LC–MS/MS identification of degradation products

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月28日

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  • Nisarg Patel,
  • Malay Pandya,
  • Foram Rawat,
  • Janki Goswami,
  • Devang Prajapati,
  • Bhumika Dudhatra,
  • Kashyap Naranbhai Thummar

摘要

A simple, robust, and reproducible reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative determination and stability assessment of Remdesivir. Forced degradation studies were conducted under acidic, alkaline, oxidative, thermal, and photolytic conditions to evaluate the intrinsic stability of the drug. Chromatographic separation was achieved on an Eclipse Plus C18 column (150 × 4.6 mm, 5 μm) using a gradient elution of 0.1% formic acid in water (mobile phase A) and acetonitrile (mobile phase B) at a flow rate of 1.0 mL/min. Detection was performed at 245 nm using a diode array detector. The method demonstrated excellent linearity over the concentration range of 2–40 µg/mL, with recovery between 98.78% and 102.05%. Validation parameters complied with ICH Q2(R1) guidelines. Degradation products generated under acidic, alkaline, and oxidative conditions were further Identified using liquid chromatography–tandem mass spectrometry (LC–MS/MS). Based on the m/z values of the degradants, probable degradation pathways were proposed. The method was successfully applied for the quantitative estimation of Remdesivir in bulk drug and injectable formulations, confirming its utility as a stability-indicating analytical tool.