SIMPLE RP-HPLC METHOD DEVELOPMENT & VALIDATION FOR ESTIMATION OF DAPAGLIFLOZIN AND METFORMIN IN MARKETEDFORMULATION

Abstract

A simple, precise, accurate, and robust RP-HPLC method was developed and validated for the simultaneous
estimation of Dapagliflozin (DAPA) and Metformin (MET) in pharmaceutical dosage forms, following ICH
Q2(R1) guidelines. Chromatographic separation was achieved with well-resolved peaks, showing retention times
of 2.05 min for MET and 9.40 min for DAPA. The method exhibited excellent linearity over the concentration
range of 5–25 µg/mL for both drugs, with correlation coefficients (r²) of 0.999. Accuracy, assessed through
recovery studies, ranged from 98.24% to 99.07% for DAPA and 98.34% to 98.85% for MET, with low %RSD
values, indicating trueness. Precision studies, including repeatability and intermediate precision, showed %RSD
values below 0.2%, confirming high reproducibility. Robustness testing demonstrated that small deliberate
changes in chromatographic conditions did not significantly affect the results. The method exhibited high
sensitivity, with LOD and LOQ values of 0.25/0.75 µg/mL for DAPA and 0.35/1.05 µg/mL for MET. Application
to commercial tablet formulations revealed assay values of 99.80% for DAPA and 99.85% for MET, with %RSD
<0.25%. The developed RP-HPLC method is suitable for routine quality control, stability studies, and
simultaneous estimation of Dapagliflozin and Metformin in combined dosage forms.