The present study introduced an innovative and quick RP-HPLC approach for simultaneous determination of Metformin HCl (MET) and Ertugliflozin L-pyroglutamamic acid (ERT). This new method is simple, accurate, precise and highly sensitive. The separation of both drugs was optimized at 40°C using HPLC column (C8, 4.6 x 150mm 5 microns) and mobile phase comprising of triethylamine in sodium octane sulfonate (pH 4) : MeOH: ACN in a ratio of 45:45:10 respectively, with a flow rate of 1.0 ml /min. The specificity of method showed that there was no interference from placebo or diluent during the drug's retention period. Accuracy and linearity studies conducted at different concentrations displayed good precision and the calibration curves exhibited high correlation i.e. R2= 0.9982 and 0.9996 for ERT and MET, respectively. Precision was assessed for repeatability and intermediate precision, both delivering satisfactory results. Robustness was evaluated under different conditions, including wavelength and flow rate variations, showing acceptable results. Limits of detection (LOD) and quantification (LOQ) demonstrated good sensitivity. The accuracy and reliability of the suggested approach for the simultaneous measurement of MET and ERT are guaranteed by the analytical method validation. Comparative analysis of the bespoke new formulation's complete dissolution profile (CDP), Ertozin-M (7.5/500mg) with innovator tablet and Segluromet (7.5/500mg) was also observed at three different pH mediums (0.1 N HCl and buffer solutions of pH 4.5 and pH 6.8). This study was conducted according to International Council for Harmonization (ICH) guideline Q2(R2) on validation of analytical procedures and Q4B annex 7(R2) for Dissolution Test. The developed HPLC method was found highly suitable for combined estimation of Metformin HCl and Ertugliflozin L-pyroglutamic acid in quality control routine analysis for development of customized pharmaceutical formulations.
Muhammad Ashraf, Shaista Zafar, Rustem Zairov, Sana Shaikh, Syed Moazzam Haider, Nida Ali, Kamran Shaikh and Mohsin Ali
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