Development and validation of a high-performance liquid chromatographic method for the determination of buspirone in pharmaceutical preparations

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 (150mm×3.0mm i.d., 5μm particle size) analytical column, results in substantial reduction in solvent consumption and increased sensitivity. The mobile phase consisted of a mixture of 0.010M ammonium acetate (pH 4.0) and methanol (55:45, v/v), pumped at a flow rate 0.30mlmin -1. The UV detector was operated at 245nm. The retention times for lidocaine (Ldc), which was used as internal standard, and buspirone were 4.57 and 7.72min, respectively. The calibration graph was ranged from 1.00 to 5.00μgml-1, while detection and quantitation limits were found to be 0.22 and 0.67μgml-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. © 2003 Elsevier B.V. All rights reserved