Determination of High Polymers in Azlocillin Sodium for Injection by Sephadex G-10 Gel Chromatography

OBJECTIVE To develop a simple method for the determination of high polymers in azlocillin sodium for injection. METHODS A SephadexTM G-10 column was used with the mobile phase A of 0.10 mol·L^-1 phosphate buffer (adjust to pH 6.8 with NaOH) at a flow rate of 1.5 mL·min^-1. And the mobile phase B was pure water, the detection wavelength was 254 nm. RESULTS The calibration curve was linear in the range of 0.001-4.08 mg·mL^-1 and the detection limit of high polymers was 0.5 μg·mL^-1. The detection potential of high polymers achieved 3 ppm by the method when the dissolved load of azlocillin sodium was 200 mg·mL^-1. CONCLUSION The proposed method is simple and reliable. It is applicable for the quality control of azlocillin sodium.