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

Abstract

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.

A Brief Review of Analytical Methods for the Estimation of TTR Kinetic Stabilizers in Pharmaceutical Formulations and Biological Matrices

“…Spectral analytical methods for TAF have not been developed, but there are some for DIF-spectrophotometry (SPM) [42] and spectrofluorimetry (SFM) [42][43][44][45]. Liquid chromatography (HPLC-UV and LC-MS) is the method of choice for the analysis of TAF plasma levels [46][47][48][49]. DIF is also quantified predominantly by HPLC [50][51][52][53][54][55][56][57][58][59] and LC-MS [60] alone [50][51][52][53]60], in combination with other drugs [54][55][56][57], metabolites [58] or impurities [59].…”

“…In the analysis of TAF in biological media, complete blood samples were collected in tubes containing ethylenediaminetetraacetic acid (EDTA) [47][48][49] or sodium citrate [46] as an anticoagulant. For complete plasma separation, the samples are allowed to stand for 30 min at 18-25 °C and centrifuged for 20 min to separate the supernatant [46].…”

“…For complete plasma separation, the samples are allowed to stand for 30 min at 18-25 °C and centrifuged for 20 min to separate the supernatant [46]. Based on the studies performed, it is recommended that plasma samples be stored at-10 to-30 °C [48] or-75 °C [46,47] and thawed at room temperature before analysis [46][47][48][49]. Sample preparation methods include PPT for the treatment of human blood plasma [46][47][48] and LLE, in the analysis of rat plasma [49].…”

“…Based on the studies performed, it is recommended that plasma samples be stored at-10 to-30 °C [48] or-75 °C [46,47] and thawed at room temperature before analysis [46][47][48][49]. Sample preparation methods include PPT for the treatment of human blood plasma [46][47][48] and LLE, in the analysis of rat plasma [49]. The PPT methods developed include pipetting 20-160 µl plasma and using 1 % trichloroacetic acid [46,47] or acetonitrile [48] as precipitating agents.…”

“…Sample preparation methods include PPT for the treatment of human blood plasma [46][47][48] and LLE, in the analysis of rat plasma [49]. The PPT methods developed include pipetting 20-160 µl plasma and using 1 % trichloroacetic acid [46,47] or acetonitrile [48] as precipitating agents. One of the HPLC methods does not use an internal standard to study the accuracy of the developed analytical procedure [46], but in the other three, a structurally similar compound was selected as an internal standard [47][48][49].…”