European Journal of Biomedical and Pharmaceutical Sciences

REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN AND METFORMIN HCL IN PURE AND PHARMACEUTICAL DOSAGE FORM

*Jagadeswaran C., Dr. Kamalakannan Dhanabalan, Dr. Manivannan R., Dinesh Kumar T., Hariharan C. and Sivakumar G.

ABSTRACT

Dapagliflozin, one of the earliest sodium-glucose transporter 2 (SGLT2) inhibitors, plays a significant role in managing type 2 diabetes mellitus (T2DM), chronic kidney disease, and heart failure. Metformin, a first-line treatment for T2DM, exerts its effects by suppressing hepatic gluconeogenesis and counteracting glucagon activity. Dapagliflozin received FDA approval on January 8, 2014, and later, on June 12, 2024, the FDA authorized AstraZeneca’s XIGDUO XR (a dapagliflozin/metformin combination) for improved glycemic control in children aged 10 years and older with T2DM. This combination therapy, complemented by a healthy diet, also aids in managing elevated levels of triglycerides and cholesterol. A comprehensive review of analytical methods used for the quantification of dapagliflozin, metformin, and their combination in bulk drugs, pharmaceutical formulations, and biological samples is presented. Techniques explored in major pharmaceutical and analytical journals include spectrophotometric methods, chromatographic methods such as HPLC, RP-HPLC, and HPTLC, as well as liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Keywords: Dapagliflozin, Metformin, Gluconeogenesis, HPLC, UV.