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Current Pharmaceutical Analysis

Editor-in-Chief

ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

Research Article

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

Author(s): Yanyan Wang, Fanlong Bu, Rui Zhang, Guiyan Yuan, Pingli Li, Xuwang Chen, Benjie Wang, Rong Li* and Ruichen Guo*

Volume 14, Issue 6, 2018

Page: [541 - 546] Pages: 6

DOI: 10.2174/1573412913666170912102907

Price: $65

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.

Graphical Abstract

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