Method Development and Validation Approaches for Ticagrelor: An In-Depth Analytical Review

Ticagrelor is a widely prescribed oral antiplatelet agent used in the management of acute coronary syndromes, where accurate and reliable analytical methods are essential to ensure its quality, safety, and therapeutic effectiveness. The development and validation of analytical procedures play a crucial role in the quantitative estimation of ticagrelor in bulk drug substances, pharmaceutical dosage forms, and biological matrices. This review presents a critical and systematic overview of the analytical methods reported for ticagrelor, with a primary focus on method development strategies and validation parameters in accordance with international regulatory guidelines. Various analytical techniques, including ultraviolet–visible spectrophotometry, high-performance liquid chromatography, liquid chromatography–mass spectrometry, and stability-indicating methods, are discussed in terms of their principles, sensitivity, specificity, and applicability in quality control and research laboratories. Emphasis is placed on method optimization, selection of chromatographic conditions, and evaluation of validation characteristics such as accuracy, precision, linearity, robustness, and limits of detection and quantification. The review also highlights recent advancements and challenges associated with ticagrelor analysis, providing insight into future perspectives for analytical method improvement. Overall, this article aims to serve as a valuable reference for researchers, analysts, and pharmaceutical professionals involved in the analytical assessment of ticagrelor.