凝胶色谱法测定比阿培南聚合物的含量

目的：建立比阿培南聚合物的测定方法。方法：采用葡聚糖凝胶SephadexG-10不锈钢柱（10min×300mm），流动相A：磷酸盐缓冲液（取磷酸氢二钾5．59g，与磷酸二氢钾0．41g，加水使其溶解成1000ml）；流动相B：水；流速为0．3ml／min；检测波长为254nm；进样量为200ul；柱温为室温；对照品采用法罗培南。结果：比阿培南在100．40～400．55mg／ml范围内，浓度与聚合物的峰面积呈良好线性关系（r=0．9999）。结论：凝胶色谱法方法简便，结果可靠，可以用于比阿培南中高分子聚合物杂质的检测。

Determination of high polyler impurities in Biapenem by gel permeation chromatography

Objective ：To develop a method for the determination of high polyer impurities in biapenem. Methods：Gel permea- tion chromatography method was adpoted.The analytical column was Sephadex G-10 stainless steel column （10 mm× 300 mm）, the mobile phase A：was phosphate buffer（dissolve 5.59 g of potassium dihydrogen phosphate and 0.41 g monopotassium phosphate in water to make 1 000 ml）, and the mobile phase B was water; The flow rate was about 0.3 ml per minute; The detective wavelength was 254 nm; The volume of injection was 200 ul; The column temperature was room temperature;Reference standards Faropenem. Results： The calibration curves of high polyler impurities in biapenem was in good linearite over the range of 100.40-400.55 mg/ml（r=0.999 9）. Conclusion： Gel permeation chromatography is sensitive, specific, accurate and reliable, it is suitable to the determination of high polyler impurities in biapenem.