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J Pharm Biomed Anal ; 35(1): 41-50, 2004 Apr 01.
Article in English | MEDLINE | ID: mdl-15030878

ABSTRACT

A stability indicating, reversed-phase high-performance liquid chromatographic method was developed and validated for the determination of buspirone (Bsp) in pharmaceutical dosage forms. The use of a semi-micro XTerra MS C18 (150 mm x 3.0 mm i.d., 5 microm particle size) analytical column, results in substantial reduction in solvent consumption and increased sensitivity. The mobile phase consisted of a mixture of 0.010 M ammonium acetate (pH 4.0) and methanol (55:45, v/v), pumped at a flow rate 0.30 ml min-1. The UV detector was operated at 245 nm. The retention times for lidocaine (Ldc), which was used as internal standard, and buspirone were 4.57 and 7.72 min, respectively. The calibration graph was ranged from 1.00 to 5.00 microg ml-1, while detection and quantitation limits were found to be 0.22 and 0.67 microg ml-1, respectively. The intra- and inter-day relative standard deviation (% R.S.D.) values were less than 1.94%, while the relative percentage error (% Er) was less than 4.0% (n = 5). The method was applied to the quality control of commercial tablets and content uniformity test and proved to be suitable for rapid and reliable quality control.


Subject(s)
Anti-Anxiety Agents/analysis , Buspirone/analysis , Chromatography, High Pressure Liquid/methods , Calibration , Chromatography, High Pressure Liquid/instrumentation , Drug Stability , Reference Standards , Reproducibility of Results , Sensitivity and Specificity , Tablets
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