Comparative Evaluation and Improvement of the Analytical Method for Amiodarone Hydrochloride: Replacing the Pharmacopeial Method with a Validated RP-HPLC Technique

This study aimed to develop and validate a rapid and robust reverse-phase high-performance liquid chromatography assay for amiodarone, creating an alternative to the previously established pharmacopeial method (retention time: 26 min). For method optimization, 20 mM of triethylamine (TEA) was added to the mobile phase buffer, followed by adjusting the organic solvent ratio and using a C18 column as the stationary phase. Under the optimized analytical conditions, the retention time of amiodarone was 5.51 min, which represents a reduction of approximately 80% compared to the previous method. Following the ICH Q2 guideline, the developed method was validated for key performance characteristics, including system suitability, specificity, linearity, accuracy, precision, and robustness. The method showed high linearity with a correlation coefficient (R2 > 0.999) across a concentration range of 0.06–0.14 mg/mL (representing 60–140% of the target concentration of 0.1 mg/mL). The analytical method developed in this study significantly reduces analysis time and costs while providing reproducible results. Therefore, it is expected to be highly useful as a routine quality control test for amiodarone generic drug products.