Determination of the antifungal agent posaconazole in human serum by HPLC with parallel column-switching technique

Neubauer, Werner; König, Armin; Bolek, Richard; Trittler, Rainer; Engelhardt, Monika; Jung, Manfred; Kümmerer, Klaus

doi:10.1016/j.jchromb.2009.06.022

Cited by 27 publications

(18 citation statements)

References 27 publications

(31 reference statements)

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“…Although the method was sensitive, it needed 250 µL of plasma sample and 50 µL of injection volume to achieve an LOQ of 0.05 µg/mL (2.5 ng on column). Neubauer et al [33] used different detector settings at 261 and 357 nm for the excitation and emission, respectively. Although the method needed only 50 µL serum, a complicate column-switching technique was used to isolate posaconazole from the serum matrix.…”

Section: Methods Comparisonmentioning

confidence: 99%

“…The technique has been proved to be the most rapid and simplest procedure for sample preparation, and is widely accepted in many clinical and analytical laboratories. Quantitative extraction of posaconazole from human plasma or serum has been reported previously by using acetonitrile [22,26,29,31], methanol [23,31,33] or mixtures of both solvents [19][20][21]25] as the extracting reagent in sample preparation. The use of perchloric acid as a precipitating agent had also been previously examined by Zhang et al [31], and the addition of perchloric acid to methanol extraction proved to be advantageous.…”

Section: Solvent Extraction In a Single Dilution Stepmentioning

confidence: 99%

“…Therapeutic drug monitoring of a patient's serum or plasma has been a useful tool to detect drug exposures outside of the therapeutic window and to help individualize a dosage regimen and treatment, increasing therapeutic efficacy, and decreasing side effects . Reported methods for the analysis of posaconazole are mostly high-performance liquid chromatography (HPLC) with mass spectrometry [13][14][15][16][17][18][19][20][21][22][23][24][25], ultraviolet [26][27][28][29][30][31] and fluorescence [32][33][34][35] detections. Mass spectrometry (MS) and tandem mass spectrometry (MS/MS) are superior in sensitivity and specificity to ultraviolet (UV) and fluorescence (FL) detections.…”

Section: Introductionmentioning

confidence: 99%

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Determination of Posaconazole in Plasma/Serum by High-Performance Liquid Chromatography with Fluorescence Detection

Tang

2017

Separations

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Abstract:A sensitive high-performance liquid chromatographic (HPLC) method is described for the determination of posaconazole in human plasma/serum. The method is based on a single dilution step by treating the sample with methanol, and followed by the direct injection of the sample into the HPLC system. Posaconazole and internal standard ketoconazole in the methanol extract are subsequently analyzed by using a fluorescence (FL) detector at optimized wavelengths (excitation 245 nm and emission 380 nm). The method achieves a linear detector response for peak height measurements over the concentration range of 0.1-10 µg/mL which adequately covers the therapeutic range for appropriate patient monitoring. The chromatographic time is less than 8 min per injection, an improvement over most published HPLC/FL or HPLC/UV methods. The method's limit of quantitation, linearity, imprecision, and accuracy met all criteria required by the Guidance for Industry Bioanalytical Method Validation. In comparison to other published methods, the current method would be of interest to analytical and clinical laboratories because it employs simple, rapid, and cost-effective procedures.

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Section: Methods Comparisonmentioning

confidence: 99%

Section: Solvent Extraction In a Single Dilution Stepmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Determination of Posaconazole in Plasma/Serum by High-Performance Liquid Chromatography with Fluorescence Detection

Tang

2017

Separations

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“…Moreover, standardization of assays for posaconazole quantification is another issue to be addressed. Various HPLC assays for quantification of posaconazole have been reported, applying either UV detection (11,21,22), fluorescence detection (FLD) (23) or mass spectrometric detection (LC-MS) (24)(25)(26)(27)(28)(29). However, inter-laboratory comparisons of different posaconazole assays have not been reported at present, and there is currently only limited availability of proficiency testing schemes.…”

Section: Introductionmentioning

confidence: 99%

Impact of glucuronide interferences on therapeutic drug monitoring of posaconazole by tandem mass spectrometry

Krüger

Vogeser

Burghardt³

et al. 2010

Clinical Chemistry and Laboratory Medicine

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Background: Posaconazole is a novel antifungal drug for oral application intended especially for therapy of invasive mycoses. Due to variable gastrointestinal absorption, adverse side effects, and suspected drug-drug interactions, therapeutic drug monitoring (TDM) of posaconazole is recommended. Method: A fast ultra performance liquid chromatographytandem mass spectrometry (UPLC-MS/MS) method for quantification of posaconazole with a run-time -3 min was developed and compared to a LC-MS/MS method and HPLC method with fluorescence detection. Results: During evaluation of UPLC-MS/MS, two earlier eluting peaks were observed in the MRM trace of posaconazole. This was only seen in patient samples, but not in spiked calibrator samples. Comparison with LC-MS/MS disclosed a significant bias with higher concentrations measured by LC-MS/MS, while UPLC-MS/MS showed excellent agreement with the commercially available HPLC method. In the LC-MS/MS procedure, comparably wide and left side shifted peaks were noticed. This could be ascribed to insource fragmentation of conjugate metabolites during electrospray ionisation. Precursor and product ion scans confirmed the assumption that the additional compounds are posaconazole glucuronides. Reducing the cone voltage led to disappearance of the glucuronide peaks. Slight modification of the LC-MS/MS method enabled separation of the main interference, leading to significantly reduced deviation. Conclusions: These results highlight the necessity to reliably eliminate interference from labile drug metabolites for cor-

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“…Therapeutic drug monitoring (TDM) of posaconazole was carried out with a previously published method based on highperformance liquid chromatography (19). The method's lower limit of quantification and limit of detection were 0.1 mg/liter and 0.05 mg/liter, respectively.…”

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confidence: 99%

Therapeutic Drug Monitoring of Posaconazole in Hematology Patients: Experience with a New High-Performance Liquid Chromatography-Based Method

Neubauer¹,

Engelhardt²,

König³

et al. 2010

Antimicrob Agents Chemother

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Parallel administration of the proton pump inhibitor (PPI) esomeprazole has been shown to decrease oral bioavailability of posaconazole in healthy volunteers. We prospectively analyzed serum samples (n ‫؍‬ 59) obtained from hematology patients (n ‫؍‬ 27) under posaconazole prophylaxis. Patients treated concomitantly with pantoprazole had significantly lower posaconazole levels than patients without PPI treatment (median levels of 630 g/liter versus 1,125 g/liter, respectively). These results suggest that drug monitoring is relevant when posaconazole and pantoprazole are administered concomitantly.

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Determination of the antifungal agent posaconazole in human serum by HPLC with parallel column-switching technique

Cited by 27 publications

References 27 publications

Determination of Posaconazole in Plasma/Serum by High-Performance Liquid Chromatography with Fluorescence Detection

Determination of Posaconazole in Plasma/Serum by High-Performance Liquid Chromatography with Fluorescence Detection

Impact of glucuronide interferences on therapeutic drug monitoring of posaconazole by tandem mass spectrometry

Therapeutic Drug Monitoring of Posaconazole in Hematology Patients: Experience with a New High-Performance Liquid Chromatography-Based Method

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