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Abstract
This study presents a novel stability-indicating method for the quantification and validation of Tafamidis using Reverse Phase High-Performance Liquid Chromatography (RP-HPLC). Tafamidis, primarily used to treat cardiomyopathy, demands stringent quality control due to its complex structure and sensitivity to environmental conditions. Our approach employs an optimized chromatographic process utilizing a YMC Triart C18 column with isocratic elution, and an initial mobile phase composed of 20mM Ammonium Acetate and Acetonitrile in a 60:40 ratio. The method showcases robust performance with a retention time of 3.3 minutes and detection at 206 nm. Validation of the method adhered to International Conference on Harmonization (ICH) guidelines, confirming the system's suitability through rigorous testing of parameters like linearity, precision, accuracy, and robustness. The method demonstrated excellent linearity within the 5-25 µg/ml range with a correlation coefficient (R²) of 0.998. Precision tests, both inter-day and intra-day, indicated consistent results with low relative standard deviation (RSD), underscoring the method’s reliability. Forced degradation studies further validated the method's efficacy in providing stability data for Tafamidis under varied conditions, revealing significant resilience to oxidative, acidic, alkaline, and thermal stresses. This validated method is both effective and efficient for routine quality control and stability testing of Tafamidis in pharmaceutical formulations, ensuring compliance with pharmacopeial standards and therapeutic efficacy.