DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN AND EMPAGLIFLOZIN
Keywords:
RP-HPLC, Metformin and Empagliflozin, QbD, Method Development, ValidationAbstract
A new simple, sensitive, suitable, precise, and robust reversed-phase high- performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of Metformin and Empagliflozin in it’s bulk and tablet dosage form. The separation was carried on an HPLC system with LC Solution software and HPLC Column C18 column (250 mm x 4.6mm; 5μm). The detection was carried out at 216 nm.
In the developed RP-HPLC method, Phosphate buffer : Acetonitrile in the ratio (60:40) v/v was used as mobile phase, at a flow rate of 1.0 mL/min and the retention time was found to be 3.3 min. The results of the analysis in the method were validated in terms of linearity, accuracy, precision, specificity, robustness . The linearity of the developed method was confirmed with a correlation coefficient (r2) of 0.9977. The RSD for the precision of the method were found less than 2.0 %. The percentage recoveries Metformin and Empagliflozin were found to be 100.09 %. The proposed method showed good predictability and robustness. The proposed method showed good predictability and robustness.
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