A Novel Analytical Method for the Simultaneous Estimation of Remogliflozin and Metformin Hydrochloride by UPLC/PDA in Bulk and Formulation Application to the Estimation of Product Traces

Objectives: A selective and novel method has been optimized for the evaluation of remogliflozin and metformin hydrochloride in bulk and in the formulation and cleaning of samples by UPLC-PDA in bulk and formulation and product traces.
Materials and Methods: The principle analytes were eluted with phosphate buffer (pH: 4.5): acetonitrile (60:40%, v/v) as the mobile phase using the Spherisorb C18, 5 μm, 4.6 mm x 150 mm analytical column with a 1.0 mL/min flow rate and a 10 μL sample volume at 245 nm in a photodiode array detector.
Results: The retention times of remogliflozin and metformin hydrochloride were 3.017 min and 5.011 min with a total run time of 8 min. The curve indicates that the correlation coefficient (r ² ) was superior with a value of 1.000 in the linear range of 10 ng/mL-100.0 ng/mL for remogliflozin and 50 ng/mL-500.0 ng/mL for metformin hydrochloride. The correlation coefficient (r ² ) for metformin hydrochloride was found to be 1.000. The lower limits of quantification and detection for remogliflozin and metformin hydrochloride were found to be 10 ng/mL and 50 ng/mL, and 5 ng/mL and 10 ng/mL, respectively.
Conclusion: The developed method was validated and applied to the bulk drug estimation and drug formulation and cleaning samples. All the results obtained with this method was accurate and precise.