Vol. 7, Issue 2, Part I (2025)

The simultaneous estimation of telmisartan and amlodipine in fixed-dose combination products presents persistent analytical challenges arising from unequal dose ratios, overlapping spectral characteristics, and increasing regulatory expectations for method robustness. This critical review systematically evaluates spectroscopic and chromatographic approaches reported for the concurrent analysis of these antihypertensive agents, with emphasis on their theoretical foundations, analytical strengths, and inherent limitations. Spectroscopic methods, including derivative, multi-wavelength, and chemometric-assisted techniques, offer simplicity and cost efficiency but remain fundamentally constrained by spectral overlap and limited intrinsic selectivity. In contrast, chromatographic methods, particularly reverse-phase high-performance liquid chromatography, achieve superior analytical assurance through physical separation of analytes and demonstrate stronger alignment with regulatory validation requirements. A structured comparative synthesis highlights the distinct roles of each methodological class within a tiered analytical framework; wherein spectroscopic techniques serve supportive or preliminary functions and chromatographic methods provide confirmatory and regulatory-acceptable quantification. By integrating theoretical analysis, regulatory considerations, and future analytical trends, this review aims to support rational method selection and informed analytical decision-making for quality control and regulatory assessment of telmisartan-amlodipine combination products.