Development and Validation of a Novel Eco-friendly green Stability indicating RP- HPLC-PDA Method for the Simultaneous Quantification of Remogliflozin etabonate and Metformin HCl in Pharmaceutical Dosage Forms
DOI:
https://doi.org/10.48047/rha65s16Keywords:
.Abstract
The project sought to establish and test an environmentally friendly stability indicating RP- HPLC method for parallel quantification of Remogliflozin etabonate and Metformin HCl in their pharmaceutical combination dosage forms according to ICH guidelines. The analysis utilized Phenomenex C18 (250 mm × 4.6 mm, 5 µ) as the chromatographic column with a 45:55% v/v ratio of 0.02 M phosphate buffer (pH 3.5 adjusted with 1% OPA) and acetonitrile as the mobile phase and it operated at 1.0 mL/min through a PDA detector which found both medications and their degradant products had excellent peak separation at 245nm. The analytical method measured Metformin HCl retention time at 2.686 min along with Remogliflozin etabonate retention time at 5.842 min. The results confirmed that Remogliflozin etabonate exhibited linear behavior within 10-50 µg/mL along with Metformin HCl showing linear behavior from 50-150 µg/mL. A % recovery between 99-100 was achieved during the analysis. The precision analyses executed on all measurements produced results with %RSD values less than 2%. Analyses indicated that LOD equaled 0.11 µg/mL and LOQ stood at 0.35 µg/mL for Remogliflozin etabonate together with 0.24 µg/mL and 0.74 µg/mL values for Metformin HCl. Research findings during forced degradation assessments revealed that Remogliflozin etabonate undergoes high degradation levels when subjected to alkali solutions. Our proposed method scored excellent results in greenness analysis through AGREE and GAPI assessments. The established method demonstrated specificity together with precision as well as affordability and environmental friendliness making it ideal for standard quality assessment and stability tests to preserve the medicine's safety and effectiveness.
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