葡聚糖凝胶色谱法分析注射用阿洛西林钠中的高聚物

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

摘要: 目的建立一个简单分析阿洛西林钠中高聚物的方法。方法采用SephadexTM G-10色谱柱，以0.1 mol·L^-1磷酸盐缓冲液(氢氧化钠调pH 6.8)为流动相A，水为流动相B，流速1.5 mL·min^-1，检测波长为254 nm。结果阿洛西林钠中高聚物在0.001~4.08 mg·mL^-1内线性关系良好，检测限为0.5 μg·mL^-1。当供试品溶解量为200 mg·mL^-1时，本法的高聚物检出能力达到百万分之三。结论所用方法简便，结果可靠，可用于阿洛西林钠中高聚物的检测。

Abstract: 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.