A Review on Analytical Strategies for the Concurrent Estimation of Metformin and Dapagliflozin

The rising clinical usage of fixed-dose combination drugs including Metformin and Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors, in particular Dapagliflozin, has necessitated the development of reliable, sensitive, and robust analytical methodologies for their simultaneous assessment. This review comprehensively summarizes and critically evaluates reported analytical techniques for the simultaneous determination of metformin and dapagliflozin in bulk drugs, pharmaceutical dosage forms, and biological matrices. Various chromatographic approaches, including RP-HPLC, UPLC, LC–MS/MS, and green micellar liquid chromatography, are discussed with respect to chromatographic conditions, detection techniques, sample preparation strategies, validation parameters, and application scopes. Advanced LC-MS/MS approaches, including as polarity switching, multiple reaction monitoring, and stable isotope-labelled internal standards, are emphasized for their higher sensitivity and selectivity in pharmacokinetic and bioequivalence studies. Stability-indicating RP-HPLC techniques capable of separating pharmaceuticals from their degradation products under controlled degradation conditions are also highlighted for quality control applications. Furthermore, eco-friendly analytical techniques and greenness assessment tools such as Analytical Eco-scale, AGREE, and MoGAPI are addressed. Overall, the reviewed methodologies are demonstrated to be suitable for routine analysis, stability studies, and clinical investigations while according to ICH standards. This work presents an integrated analytical perspective to assist researcher & analysts in selecting appropriate methodologies and driving future development of analytical methods for combination dosage forms involving more than two antidiabetic drugs.