Published:Journal of Chromatographic Science,
ISSN 0021-9665Volume
38, Number 4, April 2000, pp. 151–156
Liquid
Chromatographic Method for the Analysis of Buspirone HCl and Its Potential ImpuritiesMurat
Kartal1, Alaa Khedr2, and Adel Sakr1 1College of Pharmacy, University of Cincinnati,
Cincinnati, OH 45267-0004 and 2Faculty of Pharmacy, University of Assiut, Assiut 71516, Egypt
An accurate,
reproducible, and sensitive method for the determination of buspirone HCl and
its potential impurities is developed and validated. The validated liquid chromaography
method is conducted to meet the Food and Drug Administration/ International
Conference on Harmonization requirements for the analysis of buspirone HCl in
the presence of its impurities. Five buspirone HCl potential impurities, including
1-(2-pyrimidinyl)- piperazine (I), propargyl chloride (II), 3,3'-tetramethylene
glutarimide (III), propargyl glutarimide (IV), and the Mannich base-condensate
of I–IV fumarate (V), are separated using a mBondapack
C18 column by gradient elution with a flow rate 2.0 mL/min. The initial
mobile phase composition is 90:10 (v/v) 10mM KH2PO4 (pH
6.1)–acetonitrile. After a 1-min initial hold, a linear gradient is performed
in 26 min to 35:65 (v/v) 10mM KH2PO4 (pH 6.1)–acetonitrile.
The samples are detected at 210 and 240 nm using a photo-diode array detector.
The linear range of detection for buspirone HCl was between 1.25 ng/mL
and 500 ng/µL, with a limit of quantification of 1.25 ng/mL.
The linearity, range, peak purity, selectivity, system performance parameters,
precision, accuracy, and robustness for all of the impurities were also shown
to have acceptable values.
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