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Background <p>A robust and validated analytical method was developed for the simultaneous quantification of Efonidipine HCl Ethanolate and Metoprolol Succinate, which show a synergistic effect against thrombocytopenia. The analysis used a Shimpack C18 column (250 × 4.6&#xa0;mm, 5&#xa0;μm) with isocratic elution. The optimized mobile phase consisted of acetonitrile (ACN), Methanol, and phosphate buffer (pH 3.5) in a 65:20:15 (v/v/v) ratio, delivered at a flow rate of 1.0 mL/min. Detection was performed at 225&#xa0;nm using a photodiode array (PDA) detector. The method was validated according to ICH Q2 (R2) guidelines, and forced degradation studies were conducted under acidic (1&#xa0;N HCl), alkaline (1&#xa0;N NaOH), oxidative (3% H₂O₂), thermal (110&#xa0;°C for 3&#xa0;h), and photolytic (UV light exposure) conditions.</p> Results <p>Efonidipine and Metoprolol eluted at 7.17 and 2.77&#xa0;min, respectively, showing good linearity for EFO (20–120&#xa0;µg/mL, r² = 0.9981) and MET (12.5–75&#xa0;µg/mL, r² = 0.9961), high recovery (98–102%), and acceptable precision. The method was accurate, robust, and sensitive. Both drugs were stable under thermal and photolytic conditions but degraded under acidic, alkaline, and oxidative stress.</p> Conclusion <p>The stability-indicating method is reliable and ideal for routine analysis and stability studies in quality control lab.</p>

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Robust RP-HPLC method with forced degradation studies for the simultaneous quantification of Efonidipine HCL Ethanolate and Metoprolol succinate

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  • 发表日期：

    2025年9月6日

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  • Priyanka Malani,
  • Vineet C. Jain,
  • Zarna Dedania

摘要

Background

A robust and validated analytical method was developed for the simultaneous quantification of Efonidipine HCl Ethanolate and Metoprolol Succinate, which show a synergistic effect against thrombocytopenia. The analysis used a Shimpack C18 column (250 × 4.6 mm, 5 μm) with isocratic elution. The optimized mobile phase consisted of acetonitrile (ACN), Methanol, and phosphate buffer (pH 3.5) in a 65:20:15 (v/v/v) ratio, delivered at a flow rate of 1.0 mL/min. Detection was performed at 225 nm using a photodiode array (PDA) detector. The method was validated according to ICH Q2 (R2) guidelines, and forced degradation studies were conducted under acidic (1 N HCl), alkaline (1 N NaOH), oxidative (3% H₂O₂), thermal (110 °C for 3 h), and photolytic (UV light exposure) conditions.

Results

Efonidipine and Metoprolol eluted at 7.17 and 2.77 min, respectively, showing good linearity for EFO (20–120 µg/mL, r² = 0.9981) and MET (12.5–75 µg/mL, r² = 0.9961), high recovery (98–102%), and acceptable precision. The method was accurate, robust, and sensitive. Both drugs were stable under thermal and photolytic conditions but degraded under acidic, alkaline, and oxidative stress.

Conclusion

The stability-indicating method is reliable and ideal for routine analysis and stability studies in quality control lab.