RP-HPLC测定替比培南酯中聚合物含量
赵国敏;纪红英;王丽萍;杨琪;邢玉仁
【期刊名称】《食品与药品》 【年(卷),期】2013(000)004
【摘要】Objective To establish a RP-HPLC method for the determination of polymer in tebipenem pivoxil. Methods A RP-HPLC gradient separation was achieved on C18 Column (Waters XBridge C18, 5μm, 4.6 mm×250 mm) utilizing a mobile phase comprising of 0.025 mol/L sodium dihydrogen phosphate solution (pH was adjusted to 6.0 with 1.0 mol/L sodium hydroxide solution)-acetonitrile (50:50). The elutions from the column were detected using a variable wavelength detector at 220 nm. The column temperature was 40℃, and the flow rate of mobile phase was 1.0 mL/min. The injection volume was 10μL. Results A good linear relationship was obtained in the concentration range of 5.84-13.63μg/mL (r=0.9992). The reference solution was stable within 24h. RSD of precision of reference solution was 0.45%. The concentration limit of quantification was 0.58μg/mL, and the concentration limit of detection was 0.17μg/mL. This method showed good repeatability. Conclusion This method is sensitive, simple, accurate and reliable, and can be used in the determination of the polymer in tebipenem pivoxiln.% 目的建立RP-HPLC测定替比培南酯中聚合物含量的方法。方法采用十八烷基硅烷键合硅胶为填充剂（Waters XBridge C18，5μm，4.6 mm×250 mm），
RP-HPLC测定替比培南酯中聚合物含量
