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<p>Monitoring residual solvents in active pharmaceutical ingredients (APIs) is critical due to their potential toxicity and impact on the physicochemical stability of the final medicinal product. Therefore, strict control of these impurities is a mandatory requirement to ensure patient safety and maintain compliance with international pharmacopoeia standards and good manufacturing practices (GMP). The goal of this study was to develop and validate a sensitive method for the determination of two residual solvents using headspace gas chromatography with flame ionization detector (HS-GC-FID) in Inosine Pranobex API according to The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. A mixture of water and <i>N</i>,<i> N</i>-dimethylformamide (5:1) was selected as the sample solvent. To achieve high resolution between nonpolar <i>n</i>-hexane and polar 2-propanol, the method was implemented using a DB-624 (60&#xa0;m × 0.25&#xa0;mm × 1.4&#xa0;μm) chromatographic column with an oven temperature program and at a flow rate of 35&#xa0;cm/s. Equilibration time of the samples was 20&#xa0;min at temperature 105 °С, total run time was 43&#xa0;min. The analytical method complied with the established requirements during validation. The limit of quantification was confirmed for 2-propanol – 30 ppm, for <i>n</i>-hexane – 1 ppm. The developed method provides guaranteed purity and safety of the drug substance and is a reliable tool for controlling residual solvents at the drying stage of the technological process of synthesizing the drug substance Inosine Pranobex.</p>

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Development and validation of the analytical method for determination of residual solvents (2-propanol and n-hexane) in the drug substance Inosine Pranobex

  • 期刊论文

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  • 发表日期：

    2026年7月29日

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  • Khrystyna Chemna,
  • Liliya Logoyda,
  • Vitalii Rudiuk

摘要

Monitoring residual solvents in active pharmaceutical ingredients (APIs) is critical due to their potential toxicity and impact on the physicochemical stability of the final medicinal product. Therefore, strict control of these impurities is a mandatory requirement to ensure patient safety and maintain compliance with international pharmacopoeia standards and good manufacturing practices (GMP). The goal of this study was to develop and validate a sensitive method for the determination of two residual solvents using headspace gas chromatography with flame ionization detector (HS-GC-FID) in Inosine Pranobex API according to The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. A mixture of water and N, N-dimethylformamide (5:1) was selected as the sample solvent. To achieve high resolution between nonpolar n-hexane and polar 2-propanol, the method was implemented using a DB-624 (60 m × 0.25 mm × 1.4 μm) chromatographic column with an oven temperature program and at a flow rate of 35 cm/s. Equilibration time of the samples was 20 min at temperature 105 °С, total run time was 43 min. The analytical method complied with the established requirements during validation. The limit of quantification was confirmed for 2-propanol – 30 ppm, for n-hexane – 1 ppm. The developed method provides guaranteed purity and safety of the drug substance and is a reliable tool for controlling residual solvents at the drying stage of the technological process of synthesizing the drug substance Inosine Pranobex.