Bioanalytical Method Validation and Comparative Bioequivalence Analysis of Amiodarone in Human Plasma Using LC-MS/MS
Keywords:
bioequivalence, LC-MS/MS, Amiodarone, Human PlasmaAbstract
This study presents the development, validation, and application of a bioanalytical method for quantifying amiodarone in human plasma samples using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The validated method demonstrated specificity, sensitivity, linearity, precision, and accuracy, adhering to ICH M10 and EMEA guidelines. The calibration curve showed excellent linearity over the range of 6.25 to 600 ppb, with correlation coefficients consistently exceeding 0.99. Sample preparation utilized internal standard calibration with flecainide for accurate quantification, minimizing matrix effects. Analytical recovery was optimized with a mean deviation below 5%. The bioequivalence study involved volunteers administered with both test and reference formulations of amiodarone, analyzed at multiple time points up to 72 hours post-dosage. Pharmacokinetic parameters such as C_max, T_max, and AUC were determined, indicating bioequivalence within the acceptable regulatory limits. This robust, reproducible method is a valuable tool for clinical pharmacokinetics and therapeutic drug monitoring of amiodarone, ensuring regulatory compliance and enhanced patient care.
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