Establishment of an HPLC method for the analysis of biapenem and its impurities  

作　　者：Nan Wang Chun-Feng Li Dou-Sheng Zhang Chang-Qin Hu 

机构地区：[1]National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China

出　　处：《Journal of Chinese Pharmaceutical Sciences》2011年第2期171-180,共10页中国药学（英文版）

基　　金：Foundation item： National Key New Drag R＆D Program Foundation of China （Grant No. 2009ZX09313-027）.

摘　　要：An HPLC method for routine quality control of biapenem was established. A Dikma Diamonsil Cls column （250 mm× 4.6 mm, 5 μm） was used with diode array detection and single wavelength detection at 220 mm. The mobile phase was consisted of acetonitrile-0 1% triethylamine water （1：99, v/v）. The liner range for biapenem quantification was 0.05-10.0 mg/mL （r2- 0.999）. The LOD and LOQ of impurity were 4.8 ng （S/N 3） and 18.5 ng （S/N = 10）, respectively. Intra-day RSD of main impurity and total impurity were 1.84% and 3.37% （n = 3）; inter-day RSD of main impurity and total impurity were 4.84% and 7.58% （n = 9）. The test solution was stable when stored at 4 ℃ for 6 h. The impurity peaks of biapenem can be identified by chromatographic spectral correlation analysis using high-performance liquid chromatography~tiode array detection data from the quality control method by calculating correlation coefficients without reference standards. Two hydrolysis degradation products with relative retention times （RRTs） of 0.528 and 0.743, two dimers with RRTs of 1.062 and 2.817 were identified in the quality control chromatogram. It provides a new way to identify impurity peaks by the routine HPLC-UV method.

关 键 词：BIAPENEM HPLC-DAD Two-dimensional chromatographic spectral correlative map Identification IMPURITIES 

分 类 号：R917[医药卫生—药物分析学]