摘要

This paper describes a rapid method to determine aceglutamide (ACE) and oxiracetam (OXI) present in an injection formulation using reversed-phase high-performance liquid chromatography. The method was validated with respect to suitability, linearity, accuracy, precision and robustness. Chromatography was carried out on an Elite SinoChrom ODS-BP C18 (5 mu m, 250 x 4.60 mm) column with an isocratic mobile phase composed of methanol-phosphate buffer (pH 3.0) in the ratio of 5: 95, v/v, at a flow rate of 1.0 mL/min. Detection was carried out using a UV-PDA detector at 210 nm. The linearity range for ACE and OXI were 10-500 and 10-300 mu g/mL, respectively. The relative standard deviations for replicate measurements were always <2%.