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<p>A green micellar liquid chromatography (MLC) technique was established for simultaneous determination of dapagliflozin (DAP) and Metformin HCl (MET) in their pure and tablet dosage forms. Stability studies were carried out for both drugs using different five degradation conditions. The chromatographic separation was achieved using BDS Thermo-Hypersil C8 (150&#xa0;mm x 4.6&#xa0;mm, 5&#xa0;μm) column and hybrid micellar mobile phase composed of 50 gm of sodium lauryl sulphate in 500 mL purified water with 100mL of 2-Propanol and 3 mL triethylamine and then completed with purified water to 1000mL, and the mobile phase pH was 3.3. The (PDA) detector was used at 223&#xa0;nm, 40&#xa0;°C column temperature, 1mL/min flow rate and 20µL injection volume. The retention times of DAP and MET were (5.37 ± 0.4&#xa0;min) and (7.64 ± 0.2&#xa0;min), respectively. Linearity was constructed in ranges of (0.2–7&#xa0;µg/mL) for DAP and (50–700&#xa0;µg/mL) for MET. Mean percentage recoveries of DAP and MET were 99.88%±0.53 and 100.034%±0.60, respectively indicates good accuracy. The developed approach was validated according to ICH guidelines and efficiently applied for the analysis of DAP and MET in Dexigloflozin plus<sup>®</sup> 5/500 tablets. For the greenness assessment the analytical eco-scale, Complex MoGAPI and AGREE methods were applied.</p>

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Stability indicating green micellar liquid chromatographic method for simultaneous analysis of Metformin and dapagliflozin in their tablets

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  • 发表日期：

    2025年6月21日

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  • Aya A. Marie,
  • Mohamed G. Yassin,
  • Aya Roshdy

摘要

A green micellar liquid chromatography (MLC) technique was established for simultaneous determination of dapagliflozin (DAP) and Metformin HCl (MET) in their pure and tablet dosage forms. Stability studies were carried out for both drugs using different five degradation conditions. The chromatographic separation was achieved using BDS Thermo-Hypersil C8 (150 mm x 4.6 mm, 5 μm) column and hybrid micellar mobile phase composed of 50 gm of sodium lauryl sulphate in 500 mL purified water with 100mL of 2-Propanol and 3 mL triethylamine and then completed with purified water to 1000mL, and the mobile phase pH was 3.3. The (PDA) detector was used at 223 nm, 40 °C column temperature, 1mL/min flow rate and 20µL injection volume. The retention times of DAP and MET were (5.37 ± 0.4 min) and (7.64 ± 0.2 min), respectively. Linearity was constructed in ranges of (0.2–7 µg/mL) for DAP and (50–700 µg/mL) for MET. Mean percentage recoveries of DAP and MET were 99.88%±0.53 and 100.034%±0.60, respectively indicates good accuracy. The developed approach was validated according to ICH guidelines and efficiently applied for the analysis of DAP and MET in Dexigloflozin plus® 5/500 tablets. For the greenness assessment the analytical eco-scale, Complex MoGAPI and AGREE methods were applied.