Direct-injection HPLC method of measuring micafungin in human plasma using a novel hydrophobic/hydrophilic hybrid ODS column

Uranishi, Hiroaki; Nakamura, Mitsuhiro; Nakamura, Hiroki; Ikeda, Yōnosuke; Otsuka, Mayuko; Kato, Zenichiro; Tsuchiya, Teruo

doi:10.1016/j.jchromb.2011.03.008

Cited by 16 publications

(5 citation statements)

References 19 publications

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“…A similar on‐line HPLC method with direct sample injection was recently reported for the determination of micafungin concentrations in human plasma (Uranishi et al ., ). This very simple analytical method used a novel hydrophobic/hydrophilic hybrid ODS column, but could not obtain sufficient separation of micafungin from plasma protein.…”

Section: Resultsmentioning

confidence: 97%

“…These HPLC‐fluorescence methods are clinically useful, but sample pretreatment, such as protein precipitation with solvent (Yamato et al ., ), is required for the assay. Recently, a direct injection HPLC method was reported (Uranishi et al ., ). This method was similar to the method presented in this paper: plasma was directly injected onto an analytical column and showed good accuracy.…”

Section: Introductionmentioning

confidence: 97%

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Simple column‐switching HPLC method for determining levels of the antifungal agent micafungin in human plasma and application to patient samples

Nakagawa

Kuwabara

Kobayashi

et al. 2012

Biomedical Chromatography

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Micafungin is an echinocandin antifungal agent that is important for treating candidiasis in emergency and intensive care medicine; however, current methods for measuring micafungin plasma levels are lengthy and complicated. We report a simple quantitative method using column-switching high-performance liquid chromatography (HPLC) for determining micafungin in human plasma samples. Human plasma was directly injected into a column-switching HPLC system with a MAYI-ODS pre-column to remove the plasma matrix. The calibration curve for micafungin showed good linearity in the range 0.1-10 µg/mL in human plasma. The mean relative standard deviation value of the intra-day and inter-day precision was less than 7.3%. More than 450 successive, accurate measurements were made before the system had to be washed with ammonium acetate solution. The therapeutic micafungin level in patients' plasma was successfully measured using this method. Because the pretreatment is simple and reproducible, our method can be used for routine therapeutic monitoring.

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Section: Resultsmentioning

confidence: 97%

Section: Introductionmentioning

confidence: 97%

Simple column‐switching HPLC method for determining levels of the antifungal agent micafungin in human plasma and application to patient samples

Nakagawa

Kuwabara

Kobayashi

et al. 2012

Biomedical Chromatography

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“…Therefore, direct injection techniques that require limited or absence of sample pretreatment steps are becoming increasingly attractive in TDM. 2,3 Traditional pretreatment processes known in TDM are protein precipitation, 4 solid phase extraction, 5 and liquidliquid extraction. 6 Protein precipitation requires adding additional precipitation reagent into the blood sample followed by vortexing and centrifugation.…”

Section: Introductionmentioning

confidence: 99%

A Direct Injection Technique to Improve Biosafety to Analyze Levetiracetam Concentrations in Human Serum and Its Application in Therapeutic Drug Monitoring

Dong

Guo

Yang

et al. 2021

Therapeutic Drug Monitoring

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Background: With the outbreak of COVID-19, it has become very important to improve biosafety measures taken by medical staff. Fewer pretreatment steps correspond to lower chances of infection. The authors established a direct injection technique to analyze levetiracetam (LEV) concentrations in human serum and studied its application in therapeutic drug monitoring.Methods: Serum samples were prepared by hollow fiber centrifugal ultrafiltration and the filtrate was directly injected into a ultra-high performance liquid chromatography apparatus (Waters UPLC BEH C18 column: 50 • 2.1 mm, 1.7 mm) for analysis. The mobile phase consisted of acetonitrile and water (8:92) at a flow rate of 1.0 mL/min. The column temperature was maintained at 308C. The detected wavelength was 210 nm.Results: A linear relationship was obtained for LEV from 0.625 to 80 mcg/mL (r 2 = 0.999). The limit of detection for the analysis of LEV was 0.125 mcg/mL. The analysis time was shortened to 4 minutes. The recovery rate of LEV based on the current method was 96.6%-100.1%, whereas the absolute recovery rate was 93.2%-96.8%. The relative SD of intraday and interday precision was ,7.3%. Stability was achieved at room temperature for 24 hours after 3 freeze-thaw cycles and at 2808C for 21 days. The method was successfully applied to determine LEV concentrations in the serum of 19 patients. Conclusions:The present method is simple, accurate, and sensitive, and can improve biosafety with the direct injection technique. It is suitable for the analysis of LEV concentrations in therapeutic drug monitoring.

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“…Few HPLC methods have been reported in the literature for quantification of Micafungin in plasma [10][11][12][13] . Shengsheng et al reported stability indicating HPLC method for determination of Micafungin and related substances 14 .…”

Section: Introductionmentioning

confidence: 99%

Untitled

2016

IJPSR

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A gradient reverse phase Ultra Performance Liquid Chromatographic (RP-UPLC) method was developed and validated for determination of Micafungin sodium and its synthetic impurities. The successful separation of Micafungin sodium and its synthetic impurities was achieved using Phenomenax Aeris peptide XB C18 (150×2.1 mm i.d., 1.7 µ particle size) column maintained at 45 °C temperature with mobile phase consisting 0.01 M phosphate buffer pH 2.9 and acetonitrile in a gradient programme. The mobile phase flow rate was 0.3 ml/min and the detection wavelength was 279 nm. The retention time in developed method is comparatively less than the reported HPLC methods for determination of Micafungin sodium offering less time consuming and fast analytical method. The developed RP-UPLC method was validated according to ICH guidelines with respect to linearity, accuracy, precision, specificity and robustness and also the LOD and LOQ values were determined.

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Direct-injection HPLC method of measuring micafungin in human plasma using a novel hydrophobic/hydrophilic hybrid ODS column

Cited by 16 publications

References 19 publications

Simple column‐switching HPLC method for determining levels of the antifungal agent micafungin in human plasma and application to patient samples

Simple column‐switching HPLC method for determining levels of the antifungal agent micafungin in human plasma and application to patient samples

A Direct Injection Technique to Improve Biosafety to Analyze Levetiracetam Concentrations in Human Serum and Its Application in Therapeutic Drug Monitoring

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