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目的对注射用比阿培南聚合物进行定量检查,采用HPLC-TOF-MS法鉴别其聚合物。方法用CenturySIL C18BDS(250mm×4.6mm,5μm)色谱柱,流动相A为乙腈,B为0.01mol.L-1碳酸氢铵溶液,洗脱程序:0～27min,99%～70%B;27～40min,70%B,流速为1mL.min-1,柱温(30±0.15)℃,检测波长220nm。采用自身对照法测定比阿培南聚合物的含量,并采用高效液相色谱飞行时间质谱(HPLC-TOF-MS)鉴定聚合物杂质。结果自身对照法能准确测定比阿培南中聚合物含量,用液质联鉴定出含有2种聚合物。结论采用高效液相色谱法和液质联用技术能对比阿培南聚合物杂质进行定性定量分析,方法简易准确可行。
OBJECTIVE To quantitatively examine Biapenem for injection and identify its polymers by HPLC-TOF-MS. The method uses CenturySIL C18BDS (250mm × 4.6mm, 5μm) column, the mobile phase A is acetonitrile, B is 0.01mol.L-1 ammonium bicarbonate solution, the elution program: 0 ~ 27min, 99% ~ 70% B; ~ 40min, 70% B, flow rate 1mL.min-1, column temperature (30 ± 0.15) ℃, detection wavelength 220nm. The content of biapenem was determined by self-control method, and the polymer impurities were identified by HPLC-TOF-MS. Results Self-control method can accurately measure the polymer content of biapenem, with LC-MS identified two kinds of polymers. Conclusion High performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS / MS) can be used to qualitatively and quantitatively analyze the impurity of apenem polymer. The method is simple, accurate and feasible.