Determination of Nimodipine in Human Plasma by HPLC-ESI-MS and Its Application to a Bioequivalence Study

A simple, specific, and precise liquid chromatographic-electrospray ionization mass spectrometric (LC-ESI-MS) method has been developed for determination of nimodipine concentration in human plasma. The method involves the addition of 200 µL of saturated sodium bicarbonate (NaHCO3) solution to plasm...

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Bibliographic Details
Published in:Journal of chromatographic science 2010-02, Vol.48 (2), p.81-85
Main Authors: Zhao, Ying, Zhai, Desheng, Chen, Xijing, Yu, Qiaoling, He, Hui, Sun, Ya, Gao, Zidong, Wang, Lei, Wang, Huanhuan, Han, De'en, Ji, Hui
Format: Article
Language:English
Subjects:
Analysis
Biological and medical sciences
Calcium Channel Blockers - blood
Calcium Channel Blockers - pharmacokinetics
Calibration
Chromatography, High Pressure Liquid - methods
General pharmacology
Humans
Limit of Detection
Medical sciences
Nimodipine - blood
Nimodipine - pharmacokinetics
Pharmacology. Drug treatments
Spectrometry, Mass, Electrospray Ionization - methods
Therapeutic Equivalency
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Summary:A simple, specific, and precise liquid chromatographic-electrospray ionization mass spectrometric (LC-ESI-MS) method has been developed for determination of nimodipine concentration in human plasma. The method involves the addition of 200 µL of saturated sodium bicarbonate (NaHCO3) solution to plasma to improve the extraction recovery, liquid-liquid extraction of nimodipine from plasma samples with anhydrous diethyl ether, simple reversedphase chromatography, and ESI mass spectrometric detection in negative ion selected ion monitoring mode (SIM) using target [M-] ions at m/z 417 and m/z 359 for nimodipine and nitrendipine (internal standard, IS), respectively. A complete analytical run was achieved within 3.5 min. The limit of quantification was 0.5 ng/mL. The method was validated within a linear range of 0.5–100 ng/mL. The correlation coefficient for the calibration regression line was 0.9995 or better. Intra- and inter-batch accuracy and precision were acceptable. Analyte was stable in a battery of stability studies. The method has been successfully used in a bioequivalence study.
ISSN:0021-9665
1945-239X
DOI:10.1093/chromsci/48.2.81