Determination of itraconazole in human plasma by high-performance liquid chromatography with solid-phase extraction

Ohkubo, Tadashi; Osanai, Takako

doi:10.1258/0004563053492711

Cited by 16 publications

(7 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Antifungal therapeutic drug monitoring (TDM) could be an important tool in clinical practice if compliance is poor, the therapeutic window is narrow, or drug interactions and toxicity are common adverse effects. Therefore, quantification of drug in plasma samples is an important issue in clinical practice to improve efficacy and to decrease toxicity.Many methods to individually quantify ITZ (6,7,9,17,18,26,[31][32][33][34]37,45,46), PSC (8,35,39), and VRC (11,20,24,25,28,29,36,38) in human plasma have been published. Only one method described the quantification of the three triazoles plus fluconazole, ITC metabolite, and ketokonazole in human plasma using a solid-phase extraction procedure.…”

mentioning

confidence: 99%

Development, Validation, and Routine Application of a High-Performance Liquid Chromatography Method Coupled with a Single Mass Detector for Quantification of Itraconazole, Voriconazole, and Posaconazole in Human Plasma

Baietto

D’Avolio

Ventimiglia

et al. 2010

Antimicrob Agents Chemother

View full text Add to dashboard Cite

We have developed and validated a high-performance liquid chromatography method coupled with a mass detector to quantify itraconazole, voriconazole, and posaconazole using quinoxaline as the internal standard. The method involves protein precipitation with acetonitrile. Mean accuracy (percent deviation from the true value) and precision (relative standard deviation percentage) were less than 15%. Mean recovery was more than 80% for all drugs quantified. The lower limit of quantification was 0.031 g/ml for itraconazole and posaconazole and 0.039 g/ml for voriconazole. The calibration range tested was from 0.031 to 8 g/ml for itraconazole and posaconazole and from 0.039 to 10 g/ml for voriconazole.The incidence of mycoses has continued to increase over the past 2 decades, especially in immunocompromised patients. Notwithstanding the fact that in the last decades new antifungal agents have been approved, there is still a therapeutic need for azole compounds, such as itraconazole (ITC), posaconazole (PSC), and voriconazole (VRC), which inhibit 14a-demethylase, a key enzyme in the ergosterol biosynthesis of yeasts and molds (40).Antifungal prophylaxis, empirical therapy, and treatment of established fungal infections in the hematology patient population may be associated with significant toxicity or drug interactions, leading to subtherapeutic antifungal drug concentrations and poorer clinical outcomes (47). For example, a relationship between plasma concentrations and antifungal efficacy was shown for ITC (19), and the ratio between the area under the concentration-time curve (AUC) and MIC was identified to be predictive for the treatment efficacy of voriconazole and posaconazole, as well (1, 2). Antifungal therapeutic drug monitoring (TDM) could be an important tool in clinical practice if compliance is poor, the therapeutic window is narrow, or drug interactions and toxicity are common adverse effects. Therefore, quantification of drug in plasma samples is an important issue in clinical practice to improve efficacy and to decrease toxicity.Many methods to individually quantify ITZ (6,7,9,17,18,26,[31][32][33][34]37,45,46), PSC (8,35,39), and VRC (11,20,24,25,28,29,36,38) in human plasma have been published. Only one method described the quantification of the three triazoles plus fluconazole, ITC metabolite, and ketokonazole in human plasma using a solid-phase extraction procedure.The aim of this study was to develop and validate a high-performance liquid chromatography-mass spectrometry (HPLC-MS) method useful in routine TDM for quantitation of ITC, PSC, and VRC in human plasma using a protein precipitation extraction procedure and direct injection in an HPLC system. MATERIALS AND METHODSChemicals. ITC and dimethyl diquinoxaline (QX), used as the internal standard (IS), were purchased from Sigma Aldrich (St. Louis, MO), and PSC and VRC were purchased from Sequoia Research (Pangbourne, United Kingdom). Acetonitrile (HPLC grade) and methanol (HPLC grade) were purchased from J.T. Baker (Deventer, Holland). Formic aci...

show abstract

mentioning

confidence: 99%

Development, Validation, and Routine Application of a High-Performance Liquid Chromatography Method Coupled with a Single Mass Detector for Quantification of Itraconazole, Voriconazole, and Posaconazole in Human Plasma

Baietto

D’Avolio

Ventimiglia

et al. 2010

Antimicrob Agents Chemother

View full text Add to dashboard Cite

show abstract

“…The lowest limit of detection was 0.5 ng ml −1 , and the coefficients of variation (both intra‐assay and interassay) were less than 8.9%. Plasma itraconazole concentrations were measured using a solid phase extraction combined with the HPLC analysis method developed in our laboratory [16]. Bifonazole (30 ng) was added to the plasma samples (1 ml) as an internal standard, then the samples were diluted with 5 ml of 1 m sodium chloride and the solution briefly mixed.…”

Section: Methodsmentioning

confidence: 99%

Effect of itraconazole on the pharmacokinetics and pharmacodynamics of a single oral dose of brotizolam

Osanai

Ohkubo

Yasui

et al. 2004

Brit J Clinical Pharma

View full text Add to dashboard Cite

Br J Clin PharmacolBritish Journal of Clinical Pharmacology DOI:10.1111DOI:10. /j.1365DOI:10. -2125DOI:10. .2004 et al. Correspondence AimsTo assess the effect of itraconazole, a potent inhibitor of cy tochrome P450 (CYP)3A4, on the single oral dose pharmacokinetics and pharmacodynamics of brotizolam. MethodsIn this randomized, double-blind, cross-over trial 10 healthy male subjects received either itraconazole 200 mg or matched placebo once daily for 4 days. On day 4, a single 0.5 mg dose of brotizolam was administered orally. Plasma concentrations of brotizolam were followed up to 24 h, together with assessment of psychomotor function measured by the digit symbol substitution test (DSST), visual analogue scales and UKU side-effect rating scale. ResultsItraconazole significantly ( P < 0.001) decreased the apparent oral clearance (CL/ F ) (16.47 ± 4.3 vs 3.91 ± 2.1), increased the area under the concentration-time curves (AUC) from 0 h to 24 h (28.37 ± 10.8 vs 68.71 ± 24.1 ng ml h -1 ), and prolonged the elimination half-life (4.56 ± 1.4 vs 23.27 ± 10.3 h) of brotizolam. The AUC(0,24 h) of the DSST ( P < 0.001) and the item 'sleepiness' of UKU ( P < 0.05) were significantly decreased. ConclusionsItraconazole increases plasma concentrations of brotizolam probably via its inhibitory effect on CYP3A4 brotizolam metabolism.

show abstract

“…Itraconazole was determined by spectroscopic methods [10][11][12][13]. Different chromatographic methods were used for determination of itraconazole including GC/MS-SIM, LCMS/MS and HPLC [14][15][16][17][18][19].…”

Section: Introductionmentioning

confidence: 99%

Combining derivative and synchronous approaches for simultaneous spectrofluorimetric determination of terbinafine and itraconazole

et al. 2020

View full text Add to dashboard Cite

In this study, determination of terbinafine and itraconazole down to biological concentration level has been carried out. The determination is based on increasing the selectivity of the spectrofluorimetric technique by combining both derivative and synchronous spectrofluorometric approaches, which permits successful estimation of terbinafine at 257 nm and itraconazole at 319 nm in the presence of each other at Δ λ of 60 nm. International Conference on Harmonization validation guidelines were followed to fully validate the method, and linearity was obtained for the two drugs over the range of 0.1–0.7 µg ml −1 for terbinafine and 0.5–4.0 µg ml −1 for itraconazole. Application of the method was successfully carried out in the commercial tablets with good agreement with the comparison spectrofluorometric methods. As the detection limits were down to 0.013 and 0.1 µg ml −1 and quantitation limits were 0.04 and 0.032 µg ml −1 for terbinafine and itraconazole, respectively; the in vitro determination of terbinafine and itraconazole in spiked plasma samples was applicable. The percentage recoveries in biological samples were 97.17 ± 4.54 and 98.75 ± 2.25 for terbinafine and itraconazole, respectively. Water was used as the optimum diluting solvent in the proposed methodology which adds an eco-friendly merit.

show abstract

Determination of itraconazole in human plasma by high-performance liquid chromatography with solid-phase extraction

Abstract: Background A practical, simple, high-performance liquid chromatographic (HPLC) method is needed for the determination of itraconazole in clinical plasma samples.

Cited by 16 publications

References 23 publications

Development, Validation, and Routine Application of a High-Performance Liquid Chromatography Method Coupled with a Single Mass Detector for Quantification of Itraconazole, Voriconazole, and Posaconazole in Human Plasma

Development, Validation, and Routine Application of a High-Performance Liquid Chromatography Method Coupled with a Single Mass Detector for Quantification of Itraconazole, Voriconazole, and Posaconazole in Human Plasma

Effect of itraconazole on the pharmacokinetics and pharmacodynamics of a single oral dose of brotizolam

Combining derivative and synchronous approaches for simultaneous spectrofluorimetric determination of terbinafine and itraconazole

Contact Info

Product

Resources

About