Determination of Tafamidis Plasma Concentrations in Amyloidosis Patients with Glu89Gln Mutation by HPLC-UV Detection.

Present study describes a high-performance liquid chromatography method for the determination of the potent kinetic stabilizer—Tafamidis in human plasma. It was approved for medical use in European Union in 2011. Ultra violet (UV) detection mode and isocratic elution of the mobile phase were set and made the analytical procedure fast and widely applicable. Chromatographic determination was performed on a Purospher® RP-18 column. The mobile phase consisted of 0.1% trifluoroacetic acid in water and acetonitrile in the ratio 42:58 v/v and the flow rate was 1.0 ml/min. All analyses were carried at a room temperature and the detector was set at 280 nm. Calibration curve over a range of 1.00–10.00 μM was constructed for the purposes of linearity method validation. The specificity and effectiveness of the developed method made it suitable for observation of patients’ plasma Tafamidis concentration with time and drug therapy monitoring.