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The Development and Validation of the Accurate and Sensitive HPLC Method for Quantification of Mizoribine in Human Plasma and Its Clinical Applications

[ Vol. 14 , Issue. 6 ]

Author(s):

Yanyan Wang, Fanlong Bu, Rui Zhang, Guiyan Yuan, Pingli Li, Xuwang Chen, Benjie Wang, Rong Li* and Ruichen Guo*   Pages 541 - 546 ( 6 )

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.

Keywords:

Mizoribine, HPLC, therapeutic drug monitoring, clinical, application, validation.

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

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