acetyl-isoniazid; isoniazid; pyrazinamide; rifampicin; tuberculosis High performance liquid chromatography; Liquids; Patient monitoring; Patient treatment; Pharmacokinetics; Quality control; Antituberculosis; Coefficient of variation; Maximum concentrations; Pharmacokinetics parameters; Plasma concentration; Therapeutic drug monitoring; Therapeutic range; Tuberculosis patients; Hydrazine; acetylisoniazid; isoniazid; isoniazid plus pyrazinamide plus rifampicin; pyrazinamide; rifampicin; absorption half-life; adult; aged; analytic method; area under the curve; Article; blood analysis; drug bioavailability; drug clearance; drug distribution; drug monitoring; elimination half-life; elimination rate constant; female; high performance liquid chromatography; human; limit of detection; limit of quantitation; male; maximum concentration; pilot study; priority journal; quality control; quantitative analysis; reliability; time to maximum plasma concentration; tuberculosis
The aim of this study was to establish and validate an alternative high-performance liquid chromatography method for simultaneous quantification of pyrazinamide, isoniazid, acetyl-isoniazid and rifampicin in plasma of patients under treatment for tuberculosis. The performed method was lineal (r2> 0.99) in the range of 2.00–50.00 μg/mL for pyrazinamide, 0.50–20.00 μg/mL for both acetyl-isoniazid and isoniazid, and 1.20–25.00 μg/mL for rifampicin. Precision and trueness were demonstrated with coefficient of variation < 15%25 and deviations < 15%25, respectively, for quality controls samples. The lower limits of quantification were 2.00, 0.50, 0.50, and 1.20 μg/mL for pyrazinamide, isoniazid, acetyl-isoniazid and rifampicin, respectively. The method was applied for the analysis of plasma from patients with tuberculosis. This method allowed ensuring reliable quantification of the target compounds and their pharmacokinetics parameters. In general, the mean values of maximum concentration of each antituberculosis drug were located within their respective reference therapeutic ranges. However, patients with sub-therapeutic plasma concentrations of isoniazid and rifampicin were detected. This is the first analytical technique that simultaneously quantifies isoniazid, acetyl-isoniazid, rifampicin, and pyrazinamide concentrations from plasma samples by high-performance liquid chromatography with ultraviolet/visible. The proposed method could be applied for therapeutic drug monitoring and pharmacokinetics studies of the four compounds throughout the treatment of tuberculosis patients. © 2020 Wiley-VCH GmbH
Sanofi Aventis; Sigma Aldrich, United States
Quantification of pyrazinamide, isoniazid, acetyl-isoniazid, and rifampicin by a high-performance liquid chromatography method in human plasma from patients with tuberculosis
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Consejo Nacional de Ciencia y Tecnología, CONACYT: UASLP‐CA‐28
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