Analytical Technique Advances for Recently Approved Fixed‐Dose Combination of Dapagliflozin and Teneligliptin Hydrobromide Hydrate

ABSTRACT Most people with diabetes mellitus type 2 require more than one antihyperglycemic medication to achieve glycemic control. Products comprising one or more active components are utilized for certain indications. Several benefits, including impending therapeutic efficacy, fewer adverse drug effects, pharmacokinetic advantages, and a reduction in the dose of individual medications, justify their acceptance. To treat type 2 diabetic mellitus, a fixed‐dose tablet containing Teneligliptin (20 mg) and Dapagliflozin (DAPA) (10 or 5 mg) has recently been approved for phase III clinical trials. This review gathered and summarized the information on the stated analytical methods and physicochemical and biological characteristics of the fixed‐dose tablet formulations. The writers reviewed several credible scientific journals to achieve their goals and offered streamlined material. The published methods for Teneligliptin and DAPA include spectroscopy (42.8% and 20.7%), high performance thin layer chromatography (HPTLC) (11.4% and 9.4%), high performance liquid chromatography (37.1% and 47.1%), and hyphenated techniques (8.5% and 22.6%). The recently authorized fixed‐dose formulation would benefit from the analysts' use of such comprehensive data in their analytical methodology.