To Develop and Validate RP-HPLC Analytical Technique for the Solid Dosage Forms of Dapagliflozin and Metformin Hydrochloride

A straightforward, precise, and high-performance reverse phase liquid chromatography technique has been created for the simultaneous measurement of Metformin hydrochloride and Dapagliflozin in solid dose form. The HPLC model was used to make the determination: For chromatographic separation, an Agilent 1260 Infinity II with an Agilent 5 TC-C18 (2) 250 × 4.6mm column was utilized. PDA detector was applied. The mobile phase’s flow rate was increased to 1 milliliter per minute and contained 0.02% triethylamine: acetonitrile (50:50 v/v). A 236 nm wavelength and a 50 µl injection volume were chosen for the detection. The retention times for Dapagliflozin and metformin, when using the described approach, were determined to be 5.6 and 2.6 minutes, respectively. The linearity, accuracy, and precision of the procedure have all been confirmed. Dapagliflozin and Metformin’s linearity were in between 30 and 70 μg/ml and 0.6 and 1.4 μg/ml, respectively. Metformin and Dapagliflozin were shown to have percentage recoveries of 101.88% and 99.35%, respectively. The analytical processes are deemed suitable for their intended purpose and meet the standards outlined in ICH Q2R2, as evidenced by the results of the validation parameters.