title: Stability-indicating high-performance liquid chromatographic assay of buspirone HCl.
abstract: The 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 HCI and its potential impurities and degradation products are analyzed on an Ultrasphere C18 column heated to 40 degrees 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 HCI 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 HCI 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 HCI with some pharmaceutical excipients is studied under stress conditions. The linear range of buspirone HCI is between 5 and 200 ng/microL with a limit of quantitation of 2.5 ng/microL. 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.
authors.affiliation: College of Pharmacy, University of Cincinnati, OH 45267-0004, USA.
authors.forename: A
authors.initials: A
authors.lastname: Khedr
authors.forename: A
authors.initials: A
authors.lastname: Sakr
mesh_terms: D002065:Buspirone / Q000032:analysis* / Q000528:radiation effects; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D004355:Drug Stability; D005079:Excipients; D006358:Hot Temperature; D006868:Hydrolysis; D010084:Oxidation-Reduction; D019999:Pharmaceutical Solutions; D015203:Reproducibility of Results; D013472:Sunlight; D014465:Ultrasonics
chemical_list: D005079:Excipients; D019999:Pharmaceutical Solutions; D002065:Buspirone