APPLICATION OF QBD APPROACH IN RP-HPLCMETHODDEVELOPMENT FOR SIMULTANEOUS ESTIMATIONOFMETFORMIN HYDROCHLORIDE, SITAGLIPTINPHOSPHATE AND DAPAGLIFLOZIN PROPANEDIOLMONOHYDRATE
A new sensitive, accurate and precise high-performance liquid chromatographic technique was developedbyemploying the Quality by Design (QbD) approach to quantify metformin (MET), dapagliflozin (DAPA), andsitagliptin (SITA). The mathematical models were developed using two independent factors, includingtheconcentration of the mobile phase and the flow rate. CCD was utilised to systematically explore the response surfacemethodology and to investigate how individual components influence the response variables. In the analytical process, a mobile phase consisting of acetonitrile and 0.1% formic acid in a 1:1 ratio was employed. It was providedat a flow rate of 1 mL/min while the column was kept at 30°C. With a correlation value (R2) of 0.999, the methodshowed excellent linearity within the concentration ranges of 40–60 µg/mL for MET, 9–12 µg/mL for SITA, and0.8–1.2 µg/mL for DAPA. The MET, SITA, and DAPA were found to have respective limits of detection (LOD) and quantification (LOQ) of 2.28 and 6.90 µg/mL, 0.55 and 0.045 µg/mL, and 0.015 and 1.66 µg/mL. The %drugrecovery was in the range of 98-100% and the %RSD of less than 2% for the HPLC method. The UVmethodwasalso linear with R² 0.999; LOD and LOQ were 12.12 and 36.74 µ/ml for MET, 0.8 and 2.5 µ/ml for SITA, 0.9and2.7 µ/ml for DAPA. "Using a Quality by Design (QbD) methodology, the results verified that the RP-HPLCmethodwas effectively optimised for the simultaneous quantification of MET, SITA, and DAPA. The UVand RP-HPLCtechniques both showed dependability in terms of accuracy, precision, linearity, and cost-effectiveness after beingvalidated in compliance with ICH Q2 (R1) guidelines.
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