Stability indicating green micellar liquid chromatographic method for simultaneous analysis of Metformin and dapagliflozin in their tablets
Abstract 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 chro...
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2025-06-01
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| Online Access: | https://doi.org/10.1186/s13065-025-01537-8 |
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| author | Aya A. Marie Mohamed G. Yassin Aya Roshdy |
| author_facet | Aya A. Marie Mohamed G. Yassin Aya Roshdy |
| author_sort | Aya A. Marie |
| collection | DOAJ |
| description | Abstract 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. |
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| institution | Kabale University |
| issn | 2661-801X |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMC |
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| spelling | doaj-art-7fa86d1eb4d74531b011fb0448fca0742025-08-20T03:47:24ZengBMCBMC Chemistry2661-801X2025-06-0119111110.1186/s13065-025-01537-8Stability indicating green micellar liquid chromatographic method for simultaneous analysis of Metformin and dapagliflozin in their tabletsAya A. Marie0Mohamed G. Yassin1Aya Roshdy2Faculty of Pharmacy, Pharmaceutical Chemistry Department, Horus UniversityZeta Pharma for Pharmaceutical IndustriesFaculty of Pharmacy, Pharmaceutical Chemistry Department, Horus UniversityAbstract 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.https://doi.org/10.1186/s13065-025-01537-8Micellar liquid chromatographyStability indicatingDapagliflozinMetforminTablet dosage formGreenness assessment |
| spellingShingle | Aya A. Marie Mohamed G. Yassin Aya Roshdy Stability indicating green micellar liquid chromatographic method for simultaneous analysis of Metformin and dapagliflozin in their tablets BMC Chemistry Micellar liquid chromatography Stability indicating Dapagliflozin Metformin Tablet dosage form Greenness assessment |
| title | Stability indicating green micellar liquid chromatographic method for simultaneous analysis of Metformin and dapagliflozin in their tablets |
| title_full | Stability indicating green micellar liquid chromatographic method for simultaneous analysis of Metformin and dapagliflozin in their tablets |
| title_fullStr | Stability indicating green micellar liquid chromatographic method for simultaneous analysis of Metformin and dapagliflozin in their tablets |
| title_full_unstemmed | Stability indicating green micellar liquid chromatographic method for simultaneous analysis of Metformin and dapagliflozin in their tablets |
| title_short | Stability indicating green micellar liquid chromatographic method for simultaneous analysis of Metformin and dapagliflozin in their tablets |
| title_sort | stability indicating green micellar liquid chromatographic method for simultaneous analysis of metformin and dapagliflozin in their tablets |
| topic | Micellar liquid chromatography Stability indicating Dapagliflozin Metformin Tablet dosage form Greenness assessment |
| url | https://doi.org/10.1186/s13065-025-01537-8 |
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