title: Development and validation of a RP-HPLC method for the simultaneous determination of aceglutamide and oxiracetam in an injection formulation.
abstract: 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 μm, 250 × 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 μg/mL, respectively. The relative standard deviations for replicate measurements were always <2%.
authors.affiliation: School of Chemical and Biological Engineering, Yancheng Institute of Technology, Yancheng, China wdd0618@126.com.
authors.forename: Dandan
authors.initials: D
authors.lastname: Wang
authors.affiliation: Yancheng Products Quality Supervision and Inspection Institute, Yancheng, China.
authors.forename: Shengde
authors.initials: S
authors.lastname: Wu