Asian Journal of Pharmaceutical Analysis

Fimasartan, an angiotensin II receptor blocker (ARB), is widely used for managing hypertension and cardiovascular disorders due to its high selectivity for the AT₁ receptor. Ensuring its efficacy, safety, and regulatory compliance necessitates robust analytical methods for its quantification in bulk drugs and pharmaceutical formulations. High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), High-Performance Thin Layer Chromatography (HPTLC), and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are some of the analytical methods used for Fimasartan that are examined in this review. These methods provide high sensitivity and accuracy, making them essential for stability testing, impurity profiling, and pharmacokinetic assessments. Additionally, UV-Visible spectrophotometry has been utilized for qualitative and quantitative analysis due to its simplicity and cost-effectiveness. Furthermore, a detailed compilation of reported analytical methods including stability-indicating HPLC, LC-MS/MS, and UPLC-MS/MS techniques developed and validated across various studies is presented, showcasing key parameters like precision, retention time, detection limits, and calibration ranges. Stability-indicating methods are emphasized for detecting degradation products under stress conditions, ensuring regulatory compliance. Validation parameters set by the International Council for Harmonisation (ICH), including accuracy, precision, robustness, and specificity, are discussed. Despite the effectiveness of current techniques, challenges such as high costs and labor-intensive procedures persist. Future trends focus on automation, green chemistry practices, and AI-driven method optimization, improving efficiency and sustainability in Fimasartan analysis.