Analytical Strategies for Fixed-Dose Combination Containing Teneligliptin, Dapagliflozin, and Metformin: A Review

Type 2 diabetes mellitus is a major global health concern, and fixed-dose combinations are increasingly employed to improve glycaemic control and patient adherence. The recently approved combination of teneligliptin, dapagliflozin, and metformin HCl highlights its therapeutic relevance; however, no analytical methods are currently available for their simultaneous estimation. To address this gap, the present review compiles and critically evaluates reported analytical methods for the individual determination of these drugs, as well as their estimation in binary and other multidrug combinations. Relevant literature was systematically retrieved from ScienceDirect, Taylor & Francis, Springer, Wiley, Web of Science, Scopus, PubMed, and Google Scholar. The analysis indicates that HPLC methods predominate (≈65%), reflecting their robustness, precision, and stability-indicating capability. UV spectrophotometric methods account for approximately 25%, owing to their simplicity, cost-effectiveness, and eco-friendly nature, while HPTLC methods (≈10%) offer advantages in rapid and parallel analysis. Predominant HPLC conditions include C18 reversed-phase columns, methanol- or acetonitrile-based buffered mobile phases at mildly acidic to neutral pH, and detection wavelengths between 233 and 246 nm. Validation parameters across studies comply with ICH guidelines. Overall, this review consolidates existing analytical knowledge and identifies methodological trends to guide future method development for this fixed-dose combination.