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) 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) 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.