The simultaneous assessment of Empagliflozin, Linagliptin, and Metformin Hydrochloride in fixed-dose combination (FDC) formulations is essential for ensuring quality control, regulatory compliance, and therapeutic efficacy. This study focuses on the development, optimization, and validation of different analytical techniques for the precise and accurate quantification of these antidiabetic drugs in synthetic mixtures and pharmaceutical formulations. Various analytical methods, including high-performance liquid chromatography (HPLC), UV spectrophotometry, and high-performance thin-layer chromatography (HPTLC), were evaluated for their sensitivity, specificity, linearity, precision, and robustness. The methods were validated as per ICH guidelines, and their performance was compared based on retention time, resolution, and accuracy. Among the techniques studied, HPLC emerged as the most reliable method, providing efficient separation, high reproducibility, and minimal interference from excipients. The results confirm that the optimized analytical methods offer effective, cost-efficient, and precise approaches for the routine analysis of Empagliflozin, Linagliptin, and Metformin Hydrochloride in pharmaceutical formulations. The study highlights the significance of selecting an appropriate analytical technique based on sensitivity, simplicity, and regulatory requirements for ensuring drug quality and formulation standardization. Further research may focus on stability studies and pharmacokinetic applications using these validated methods.

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