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*, Ruichen Guo*.

Journal Name: Current Pharmaceutical Analysis

Volume 14 , Issue 6 , 2018

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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.

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Article Details

VOLUME: 14
ISSUE: 6
Year: 2018
Page: [541 - 546]
Pages: 6
DOI: 10.2174/1573412913666170912102907
Price: $58

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