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.
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A direct potentiometric titration method was applied for determination of Lisinopril Dihydrate. The method was based on the treatment of the primary data with nonlinear regression procedure. An accessible and easy-to-use algorithm for the evaluation (quantification) of a system with acid-base properties has been developed to provide a quick and unambiguous answer for the quantitative content of Lisinopril Dihydrate. The acid-base constants of Lisinopril Dihydrate were determined in aqueous solutions (at constant ionic strength 0.2 mol/l KCl and temperature 25°C). The potentiometric method developed was validated according to ICH and shows very good accuracy and precision. The present approach can be successfully used in routine analysis of the drug in quality control laboratories.
Transthyretin kinetic stabilizers are used as first-line drug therapy for transthyretin amyloid polyneuropathy mostly in patients unsuitable for liver transplantation. The two drugs prescribed in clinical practice are Tafamidis and Diflunisal. The European Medicines Agency approved Tafamidis for this prescription in 2011 and 2019 American Food and Drug Association also registered it for the same use. Diflunisal is a non-steroidal anti-inflammatory drug but its structural similarities to Tafamidis determine its “off-label” use for such clinical conditions. This review article represents the various analytical methods available in published literature for the determination of Tafamidis and Diflunisal in bulk drugs, pharmaceutical formulations, and biological matrices. Detailed information about all developed quantitative methods consisting of spectrophotometry, spectrofluorimetry, high-performance liquid chromatography with ultraviolet, fluorescence or diode array detection, liquid chromatography-tandem mass spectrometry, and voltammetry is provided and can be effectively used in the development of new analytical procedures and routine drug manufacturing or clinical practice.
Background: Transthyretin amyloidosis is a rare disease currently under wide investigation and many different therapeutic agents were developed for its control and treatment. In addition to the newly discovered drugs, it was also observed drug repurposing of some wellstudied therapeutic agents. Diflunisal was developed in 1971 as an anti-inflammatory and analgesic drug but showed good results when used as a kinetic stabilizer of the transthyretin protein. Objectives: Present study describes a high-performance liquid chromatography method for its determination in bulk drug and human plasma by UV detection. Materials and Methods: Isocratic elution of the mobile phase (consisting of 0.1% trifluoroacetic acid in water and acetonitrile in the ratio 42:58 v/v) at a flow rate 1.0 ml/min was set and the developed analytical procedure became fast and simple. Chromatographic determination was performed on a Purospher ® RP -18 column at room temperature and a UV detector set at 230 nm. Results: The developed method was validated for linearity in the range 0.5-125 µg/ml for the bulk drug and 0.48-120 µg/ml for plasma. Calibration curves were linear over the selected ranges with correlation coefficients (R 2 ) greater than 0.999. The coefficients of variation for intra-and interassay were <2% for both methods -bulk drug and plasma determination. Conclusion: The developed effective and specific method can be applied in routine clinical practice for drug therapy monitoring.
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