反相高效液相色谱法测定注射用比阿培南聚合物杂质含量  

RP-HPLC determination of biapenem polymer impurities

作　　者：蔡洪鲲[1,2] 孙国祥[1] 胡玥珊[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]湖南省益阳市药品检验所,湖南益阳413000

出　　处：《中南药学》2011年第12期904-906,共3页Central South Pharmacy

摘　　要：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 develop an RP-HPLC method for the determination of injectable biapenem polymer impuri- ties, and identify the polymer impurities in biapenem by HPLC-TOF-MS. Methods The operation was carried out on a Century SIL C18 BDS column （250 mm×4. 6 mm, 5μm）, with mobile phase A consisting of acetonitrile, and mo- bile phase B consisting of 0. 01 mol · L^-1 ammonium bicarbonate solution. The gradient program was used from 0 to 27 min, the proportion of mobile phase B volume changed from 99% to 70% ; from 27 to 40 min, the proportion of mobile phase B volume maintained at 70%, the flow rate was 1 mL · min^-1, the column temperature was （30±0. 15） ℃, and the detection wavelength was 220 nm. The content of biapenem polymer was determined by self-control contrast method, and identified by HPLC-TOF-MS. Results Biapenem polymer impurities were determined by self- control contrast. The 2 polymer impurities were identified by HPLC-MS. Conclusion Biapenem polymer impurities can be qualitatively and quantitatively analyzed by HPLC and HPLC-TOF MS. The methods is simple, accurate, and feasible.

关 键 词：反相高效液相色谱法 高效液相色谱-飞行时间质谱 比阿培南 自身对照法 聚合物杂质 

分 类 号：R917[医药卫生—药物分析学]