AI-Assisted Stability-Indicating RP - HPLC Method Development and Validation for the Quantitative Estimation of Tafamidis in Bulk Drug and Pharmaceutical Dosage Forms

Abstract

A stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitative estimation of Tafamidis in bulk drug and pharmaceutical dosage forms. Chromatographic separation was achieved using a Phenomenex Gemini ODS C18 column (250 × 4.6 mm, 5 µm) with methanol and phosphate buffer (25:75, v/v) as the mobile phase at a flow rate of 1.0 mL/min. Detection was performed at 312 nm using a PDA detector. The method was evaluated for system suitability, specificity, linearity, accuracy, precision, intermediate precision, robustness, limit of detection, limit of quantification, and stability-indicating capability. Tafamidis showed a mean retention time of approximately 3.16 min and linear response over the concentration range of 10–50 µg/mL, with a correlation coefficient of 0.999. The assay of the pharmaceutical dosage form was 99.23%. Recovery at the evaluated concentration levels was approximately 100.41–100.44%, while method precision and intermediate precision showed low percentage relative standard deviations. The calculated LOD and LOQ were 0.597 and 1.811 µg/mL, respectively. Forced-degradation studies under acidic, alkaline, oxidative, thermal, photolytic, and hydrolytic conditions demonstrated separation of Tafamidis from degradation products. The experimental dataset also provides a basis for future evaluation of artificial intelligence and machine-learning approaches for chromatographic optimisation; however, such models were not used to generate the reported validation results.