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<p>A simple, selective, and environmentally sustainable RP-HPLC method was developed for simultaneous quantification of gabapentin (GAB) and Methylcobalamin (MET) in pharmaceutical products. Separation was achieved on a Zorbax Eclipse C8 column (150 × 4.6&#xa0;mm, 3.5&#xa0;μm) using a green mobile phase of potassium phosphate buffer (pH 6.9)/acetonitrile (95:5 v/v) at 2.0 mL/min, with detection at 210&#xa0;nm. Total analysis time was 10&#xa0;min with 100 µL injection volume. The method showed excellent linearity (3–50&#xa0;µg/mL; R² &gt; 0.9998), LODs (0.60–0.80&#xa0;µg/mL), and LOQs (2.00–2.50&#xa0;µg/mL). Environmental sustainability was validated by multiple metrics: AGREE (0.70), AGREEprep (0.71), and Analytical Eco-Scale (80), confirming superior greenness. Forced degradation studies demonstrated stability-indicating capability per ICH guidelines. This eco-friendly approach provides a reliable solution for quality control of GAB/MET formulations while minimizing environmental impact.</p>

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Green and white analytical approach for parallel quantification of gabapentin and methylcobalamin in medicinal products using inventive RP-HPLC technique

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月23日

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  • Samar M. Mahgoub,
  • Fahad M. Alminderej,
  • Ammena Y. Binsaleh,
  • Bandar R. Alsehli,
  • Sayed M. Saleh,
  • Mahmoud A. Mohamed

摘要

A simple, selective, and environmentally sustainable RP-HPLC method was developed for simultaneous quantification of gabapentin (GAB) and Methylcobalamin (MET) in pharmaceutical products. Separation was achieved on a Zorbax Eclipse C8 column (150 × 4.6 mm, 3.5 μm) using a green mobile phase of potassium phosphate buffer (pH 6.9)/acetonitrile (95:5 v/v) at 2.0 mL/min, with detection at 210 nm. Total analysis time was 10 min with 100 µL injection volume. The method showed excellent linearity (3–50 µg/mL; R² > 0.9998), LODs (0.60–0.80 µg/mL), and LOQs (2.00–2.50 µg/mL). Environmental sustainability was validated by multiple metrics: AGREE (0.70), AGREEprep (0.71), and Analytical Eco-Scale (80), confirming superior greenness. Forced degradation studies demonstrated stability-indicating capability per ICH guidelines. This eco-friendly approach provides a reliable solution for quality control of GAB/MET formulations while minimizing environmental impact.