Title:The Development and Validation of the Accurate and Sensitive HPLC Method for Quantification of Mizoribine in Human Plasma and Its Clinical Applications
VOLUME: 14 ISSUE: 6
Author(s):Yanyan Wang, Fanlong Bu, Rui Zhang, Guiyan Yuan, Pingli Li, Xuwang Chen, Benjie Wang, Rong Li* and Ruichen Guo*
Affiliation:Institute of Clinical Pharmacology, Qi Lu Hospital of Shandong University, Jinan, Institute of Clinical Pharmacology, Qi Lu Hospital of Shandong University, Jinan, Institute of Clinical Pharmacology, Qi Lu Hospital of Shandong University, Jinan, Institute of Clinical Pharmacology, Qi Lu Hospital of Shandong University, Jinan, Institute of Clinical Pharmacology, Qi Lu Hospital of Shandong University, Jinan, Institute of Clinical Pharmacology, Qi Lu Hospital of Shandong University, Jinan, Institute of Clinical Pharmacology, Qi Lu Hospital of Shandong University, Jinan, Institute of Clinical Pharmacology, Qi Lu Hospital of Shandong University, Jinan, Institute of Clinical Pharmacology, Qi Lu Hospital of Shandong University, Jinan
Keywords:Mizoribine, HPLC, therapeutic drug monitoring, clinical, application, validation.
Abstract:Background and Objectives: To establish a simple and reproducible High Performance Liquid
Chromatography (HPLC) method for the determination of mizoribine in human plasma using glipizide
as Internal Standard (IS).
Methods: The mizoribine in plasma was precipitated with 10% perchloric acid and separated on a Phenomenex
Luna NH2 (250 mm × 4.6 mm, 5 µm) column with a mobile phase consisted of acetonitrile
and 0.3% glacial acetic acid aqueous solution (48:52, V/V) at a flow rate of 1.0 mL/min. The detection
wavelength was 280 nm and the column temperature was room temperature.
Results: The assay exhibited a linear range of 0.05-10.0 µg/mL (r = 0.9992) and the lower limit of quantification
was 0.05 µg/mL. The specificity, linearity, accuracy, precision and stability were in accordance
to China Food and Drug Administration (CFDA) guidelines.
Conclusion: Therefore, the method was successfully applied in the routine therapeutic mizoribine
monitoring in Chinese kidney transplant patients after an oral administration of 100 mg (2 Bredinin® 50
mg tablets) or 150 mg (3 Bredinin® 50 mg tablets) mizoribine.
