LC-MS/MS method for determination of r-RGD-hirudin in human plasma and its application in pharmacokinetic study
Bioanalytical method published in Analytical Biochemistry (2022)
Abstract
OBJECTIVE: This study aimed to develop a simple, sensitive, and selective Liquid chromatography with a Mass spectroscopic method for simultaneous quantification of a recombinant bifunctional hirudin (r-RGD-Hirudin, Bifunctional Hirudin, BFH) in human plasma and verify its effectiveness. METHODS: The analytes and the internal standards from human plasma were extracted using the solid-phase extraction technique. The reconstituted samples were chromatographed on Waters C18 column (BEH 50 × 2.1 mm, 1.7 μm) using a mixture of 0.1% formic acid/acetonitrile (85%/15%, v/v) with gradient elution as the initial mobile phase at a flow rate of 0.3 mL/min. RESULTS: The effectiveness of the proposed method was verified over the concentration range of 10-2000 ng/mL for r-RGD-Hirudin. A linear calibration curve was obtained. The precision and accuracy of BFH in the intra- and inter-day runs fell within the range of ±15% at LQC, GMQC, MQC and HQC concentrations. The extraction recoveries and matrix effect at two quality control (QC) levels for BFH were confirmed to conform to the relevant requirement. CONCLUSION: The proposed method was successfully adapted to examine the pharmacokinetics of BFH in 40 Chinese healthy volunteers, respectively.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Zusammenfassung
Develops and validates an LC-MS/MS assay for r-RGD-hirudin (engineered antiplatelet-anticoagulant chimera) in human plasma — applied to phase I PK study.
Warum dies für die Hirudotherapie relevant ist
This study developed and validated an LC-MS/MS method for the quantification of recombinant bifunctional hirudin (r-RGD-Hirudin, BFH) in human plasma using solid-phase extraction, with a linear calibration range of 10–2000 ng/mL and acceptable precision, accuracy, recovery, and matrix effect. The method was then applied to examine the pharmacokinetics of BFH in 40 healthy Chinese volunteers. For ASH's domain, this is methodologically relevant because it establishes an analytical tool for measuring a recombinant hirudin derivative in human plasma, supporting pharmacokinetic characterization of hirudin-based therapeutics. Caveat: the abstract describes only bioanalytical method development and a pharmacokinetic application with no efficacy, safety, or clinical outcome data, and BFH is an engineered bifunctional construct distinct from native leech therapy.
Zitation
LC-MS/MS method for determination of r-RGD-hirudin in human plasma and its application in pharmacokinetic study.
Peng A et al. · Analytical biochemistry, 2022
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