A Simple Validated LC/MS-MS Method for Determination of Amiodarone in Human Plasma

Context: Amiodarone (AD) is a commonly used anti-arrhythmic drug that can treat and prevent a variety of cardiac arrhythmias. Aims: The aim is to establish a high-throughput, accurate, and sensitive technique for measuring AD in human plasma Materials and Methods: A liquid chromatographic–mass spectrometric method was developed with using the HSST3, 50 × 2.1 mm, Waters column. Chlorpheniramine maleate was utilized as the internal standard (IS) along with a mobile phase consisting of methanol and 0.1% aqueous formic acid (90:10, v/v) at a flow rate of 0.65 mL/min. AD was determined by the electrospray positive ionization mode. Results: The proposed method has been validated through following ICH guidelines. With good recovery percentages ranging from 95% to 99%, standardization curves for AD showed a good linearity in a range of 1.0–200.0 ng/mL. Accuracy and precision were performed both within and between days, and the results were within acceptable bounds (98–102% for accuracy and ≤ 2% of relative standard deviation for precision). Conclusion: The developed method is accurate, precise, and sensitive for AD measurement. It allows the analysis of many plasma samples per a single day due to short run time, which is suitable for routine analysis of AD.