Dataset Information

Determination of Bendamustine in Human Plasma and Urine by LC-FL Methods: Application in a Drug Monitoring.

ABSTRACT: Simple and sensitive liquid chromatography (LC) methods with fluorescence (FL) detection for the determination of bendamustine (BM) in human plasma and urine were developed and validated. The procedure of BM extraction from a plasma sample involved solid-phase extraction with a C18 SPE column, while liquid-liquid extraction with dichloromethane was applied for a urine sample. In both methods, cinoxacin was used as the internal standard. Chromatographic separations were performed on a Synergi Max-RP column, while FL detector was set at the excitation wavelength of 328 nm and the emission wavelength of 420 nm. The LC-FL methods were validated for accuracy, precision, selectivity, linearity, recovery, and stability. The detection limits for BM were 0.5 and 2.5 ng mL(-1) in plasma and urine, respectively. The intra-day and inter-day precisions were less than 9.86 %, while the accuracies were higher than 92.63 and 94.29 % for BM in plasma and urine, respectively. The proposed LC-FL methods were sensitive, robust, and specific, allowing reliable drug quantification in plasma and urine samples. The methodologies were successfully applied to monitoring of BM in a child with cancer treated with BM.

SUBMITTER: Plenis A

PROVIDER: S-EPMC4930483 | biostudies-other | 2016

REPOSITORIES: biostudies-other

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Determination of Bendamustine in Human Plasma and Urine by LC-FL Methods: Application in a Drug Monitoring.

Plenis Alina A Frolow Agnieszka A Rekowska Natalia N Olędzka Ilona I Kowalski Piotr P Bień Ewa E Krawczyk Małgorzata Anna MA Adamkiewicz-Drożynska Elżbieta E Bączek Tomasz T

Chromatographia 20160518

Simple and sensitive liquid chromatography (LC) methods with fluorescence (FL) detection for the determination of bendamustine (BM) in human plasma and urine were developed and validated. The procedure of BM extraction from a plasma sample involved solid-phase extraction with a C18 SPE column, while liquid-liquid extraction with dichloromethane was applied for a urine sample. In both methods, cinoxacin was used as the internal standard. Chromatographic separations were performed on a Synergi Max ...[more]

PMID: 27429473

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Project description:Neurocryptococcosis, a meningoencephalitis caused by Cryptococcus spp, is treated with amphotericin B (AmB) combined with fluconazole. The integrity of the brain-blood barrier and the composition of the cerebrospinal fluid (CSF) may change due to infectious and/or inflammatory diseases such as neurocryptococcosis allowing for the penetration of AmB into the central nervous system. The present study aimed to develop LC-MS/MS methods capable of quantifying AmB in CSF at any given time of the treatment in addition to plasma, plasma ultrafiltrate, with sensitivity compatible with the low concentrations of AmB reported in the CSF. The methods were successfully validated in the four matrices (25 μl, 5-1,000 ng ml-1 for plasma or urine; 100 μl, 0.625-250 ng ml-1 for plasma ultrafiltrate; 100 μl, 0.1-250 ng ml-1 for CSF) using protein precipitation. The methods were applied to investigate the pharmacokinetics of AmB following infusions of 100 mg every 24 h for 16 days administered as a lipid complex throughout the treatment of a neurocryptococcosis male patient. The methods allowed for a detailed description of the pharmacokinetic parameters in the assessed patient in the beginning (4th day) and end of the treatment with AmB (16th day), with total clearances of 7.21 and 4.25 L h-1, hepatic clearances of 7.15 and 4.22 L h-1, volumes of distribution of 302.94 and 206.89 L, and unbound fractions in plasma ranging from 2.26 to 3.25%. AmB was quantified in two CSF samples collected throughout the treatment with concentrations of 12.26 and 18.45 ng ml-1 on the 8th and 15th days of the treatment, respectively. The total concentration of AmB in plasma was 31 and 20 times higher than in CSF. The unbound concentration in plasma accounted for 77 and 44% of the respective concentrations in CSF. In conclusion, the present study described the most complete and sensitive method for AmB analysis in plasma, plasma ultrafiltrate, urine, and CSF applied to a clinical pharmacokinetic study following the administration of the drug as a lipid complex in one patient with neurocryptococcosis. The method can be applied to investigate the pharmacokinetics of AmB in CSF at any given time of the treatment.

Dataset Information

Determination of Bendamustine in Human Plasma and Urine by LC-FL Methods: Application in a Drug Monitoring.

Publications

Determination of Bendamustine in Human Plasma and Urine by LC-FL Methods: Application in a Drug Monitoring.

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