The stability of biapenem and structural identification of impurities in aqueous solution

被引：39

作者：

Xia, Ming ^{[1
]}

Hang, Tai-Jun ^{[2
]}

Zhang, Fei ^{[1
]}

Li, Xiao-Min ^{[1
]}

Xu, Xiang-Yang ^{[1
]}

机构：

[1] Jiangsu Simcere Pharmaceut R&D Co Ltd, Dept Pharm, Nanjing 210042, Peoples R China

[2] China Pharmaceut Univ, Dept Pharmaceut Anal, Nanjing 210009, Peoples R China

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2009年 / 49卷 / 04期

关键词：

Biapenem; Stability; Degradation products; Dimeric impurity; HPLC-MS; AMOXICILLIN; DEGRADATION; IMIPENEM;

D O I：

10.1016/j.jpba.2009.02.002

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

The stability of biapenem in aqueous solution was investigated. Forced degradation of biapenem was carried out under different concentrations, pH values and temperatures. The degradation products were determined by reverse-phase HPLC and identified by LC-MS/MS. One dimeric impurity was obtained by reverse-phase preparative HPLC and characterized by LC-MS/MS and NMR. A possible degradation mechanism has been presented. (c) 2009 Elsevier B.V. All rights reserved.

引用

页码：937 / 944

页数：8

共 9 条

[1] Chromatographic determination of high-molecular weight impurities in amoxicillin [J].

Cai, SY ;

Hu, CQ ;

Xu, MZ .

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2003, 31 (03) :589-596

[2] Effect of initial concentration on stability of panipenem in aqueous solution [J].

Ito, N ;

Suzuki, M ;

Kusai, A ;

Takayama, K .

CHEMICAL & PHARMACEUTICAL BULLETIN, 2005, 53 (03) :323-327

[3] Identification of dimer impurities in ampicillin and amoxicillin by capillary LC and tandem mass spectrometry [J].

Lu, Chi-Yu ;

Feng, Chia-Hsien .

JOURNAL OF SEPARATION SCIENCE, 2007, 30 (03) :329-332

[4] Biapenem [J].

Perry, CM ;

Ibbotson, T .

DRUGS, 2002, 62 (15) :2221-2234

[5] FORMATION, ISOLATION AND IDENTIFICATION OF OLIGOMERS OF AZTREONAM [J].

RANADIVE, SA ;

PIPKIN, JD ;

VARIA, SA ;

CHANG, NH ;

BARRY, EP ;

PORUBCAN, M ;

UNGER, SE .

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, 1995, 3 (05) :281-291

[6] STUDIES ON THE STRUCTURES OF IMIPENEM, DEHYDROPEPTIDASE-I HYDROLYZED IMIPENEM, AND RELATED ANALOGS [J].

RATCLIFFE, RW ;

WILDONGER, KJ ;

DIMICHELE, L ;

DOUGLAS, AW ;

HAJDU, R ;

GOEGELMAN, RT ;

SPRINGER, JP ;

HIRSHFIELD, J .

JOURNAL OF ORGANIC CHEMISTRY, 1989, 54 (03) :653-660

[7] Preparation, isolation, and characterization of dimeric degradation products of the 1β-methylcarbapenem antibiotic, ertapenem [J].

Sajonz, P ;

Natishan, TK ;

Wu, Y ;

Williams, JM ;

Pipik, B ;

DiMichele, L ;

Novak, T ;

Pitzenberger, S ;

Dubost, D ;

Almarsson, Ö .

JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES, 2001, 24 (19) :2999-3015

[8] STABILITY AND KINETICS OF DEGRADATION OF IMIPENEM IN AQUEOUS-SOLUTION [J].

SMITH, GB ;

DEZENY, GC ;

DOUGLAS, AW .

JOURNAL OF PHARMACEUTICAL SCIENCES, 1990, 79 (08) :732-740

[9] Simple and rapid analytical method for carbapenems using capillary zone electrophoresis [J].

Taniguchi, S ;

Hamase, K ;

Kinoshita, A ;

Zaitsu, K .

JOURNAL OF CHROMATOGRAPHY B, 1999, 727 (1-2) :219-225

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