Published:Journal of Chromatographic Science,
ISSN 0021-9665Volume 37, Number
12, December 1999, pp. 462-468
Stability-Indicating
High-Performance Liquid Chromatographic Assay of Buspirone HCl
Alaa
Khedr and Adel SakrThe
United States Pharmacopoeia high-performance liquid chromatographic (HPLC) assay
method of buspirone is not able to discriminate buspirone from its degradation
products. The purpose of this work is to develop a sensitive, selective, and validated
stability-indicating HPLC assay for the analysis of a buspirone hydrochloride
in a bulk drug. Buspirone HCl and its potential impurities and degradation products
are analyzed on an Ultrasphere C18 column heated to 40°C using a gradient
program that contains monobasic potassium phosphate buffer solution (pH 6.9) and
acetonitrile–methanol mixture (13:17) of 35% for 5 minutes, then increased
to 54% in 5.5 minutes. The samples are monitored using a photo-diode array detector
and integrated at 244 and 210 nm. The stress testing of buspirone HCl shows that
buspirone acid hydrochloride is the major degradation product. The developed method
shows a separation of buspirone degradation product and its potential impurities
in one run. The stability of buspirone HCl is studied under accelerated conditions
in order to provide a rapid indication of differences that might result from a
change in the manufacturing process or source of the sample. The forced degradation
conditions include the effect of heat, moisture, light, acid–base hydrolysis,
sonication, and oxidation. The compatibility of buspirone HCl with some pharmaceutical
excipients is studied under stress conditions. The linear range of buspirone HCl
is between 5 and 200 ng/µL with a limit of quantitation of 2.5 ng/µL.
The intraassay percentage deviation is not more than 0.38%, and the day-to-day
variation was not more than 0.80%. The selectivity, repeatability, linearity,
range, accuracy, sample solution stability, ruggedness, and robustness show acceptable
values.
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