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Articles Related to Human Plasma

Reversed-Phase High Performance Liquid Chromatography Procedure for the Determination of Isavuconazole in Human Plasma

Introduction: Isavuconazole is an antifungal drug used for treating patients with invasive fungal infections. Efficacy and safety of isavuconazole is monitored by measuring plasma isavuconazole concentration using LCMS which is a non-affordable method. We used the HPLC system with a UV detector to measure plasma Isavuconazole concentration. Objective: Improved Reversed-phase high performance liquid chromatography procedure with UV detection is described which is cost effective, simple, precise and easily processed for the measurement of Isavuconazole, a drug used to treat the patients with invasive fungal infections, in blood plasma. Method: The method involves protein precipitation, addition of ammonium dihydrogen phosphate and chromatographic separation on a Hypurity C18 Column using an isocratic mobile phase of acetonitrile and ammonium acetate buffer (pH 8.0, 10 mM) (55:45, v/v). The UV detection was performed at 285 nm. The method provides rapid resolution of Isavuconazole in a 50 uL injection. Result: Lower limit of Quantification (LLOQ) is 0.25 μg/ml in a 50 uL injection volume for Isavuconazole with a recovery consistently > 100 %. The assay is validated over linear range of 0.25 to 10 μg/ml. The intra-assay precision is < 3.53 % and inter-assay is <6.38% relative standard deviation of Isavuconazole. The method demonstrated clean separation, clinically acceptable detection limit and a linear range upto 25 ug/mL. Conclusion: The assay demonstrated applicability in quantifying the drug level and monitoring the therapeutic dose for maintaining effective biological level to have better response in fungal infected patients. The method is cheaper as compared to LC-MS/MS and Tandem Mass spectrometry and the results are reportable on the same day of blood collection.
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Determination of N-Butylscopolamine in Human Plasma by Solid-Phase Extraction and UHPLC-ESI-MS/MS: Development, Validation and Application to a Bioequivalence Study

BioequivalenceA sensitive ultra performance liquid chromatography-electrospray ionization-tandem mass spectrometry (UHPLC-ESI-MS/MS) method for measurements of N-butylscopolamine in plasma was developed and validated. A SPE extraction was proposed for the clean up of plasma and N-butylscopolamine-d9 was added as internal standard. The analyses were carried out using a phenyl column and mobile phase of acetonitrile:
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Development and Optimization of an LC-MS/MS Method for Dosage Form of Ergocalciferol (Vitamin D2 ) in Human Plasma

Accurate measurement of ergocalciferol in biological samples has become easier using high-end mass spectra. Currently, various LCMS/MS methods have been developed to quantify ergocalciferol. Use of LC-MS/MS has accomplished to develop an accurate method that could quantify ergocalciferol in a large number of samples where it should be analyzed in the blood immediately after dosage. The objective of this study is to optimize chromatographic conditions and evaluate the LC-MS/MS method for accurate quantification of the dosage form of ergocalciferol in human plasma. Extraction and separation of ergocalciferol in human plasma was achieved using methanol liquid-liquid extraction and by a reverse phase C8 column, respectively
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Development of a Stability Indicating UPLC-MS/MS Method for Rapid and Reliable Determination of Fenofibrate in Marketed Product (Lypanthyl® 200M) and Human Plasma

A reliable, fast, sensitive and selective Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry (UPLC-MS/MS) method has been developed and validated for the determination of fenofibrate in marketed product (Lipanthyl) and human plasma. The chromatographic separation was performed on a reversed-phase Acquity®BEH C18 column (1.7 μm particle size, 50 mm x 2.1 mm ID) with an isocratic elution profile and mobile phase consisting of methanol and water (80:20, %, v/v). To achieve optimum chromatographic condition the influence of mobile phase composition and flow rate was investigated. The total chromatographic analysis time was as short as 2 min.
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Editorial Board Members Related to Human Plasma

Baolin Zhang

Division of Therapeutic Proteins
Office of Biotechnology Products
FDA/Center for Drug Evaluation and Research
United States
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