Evaluation of liquid chromatography methods for the separation of ampicillin and its related substances

被引：12
作者：
Zhu, YX
Roets, E
Ni, ZG
Moreno, ML
Porqueras, E
Hoogmartens, J
机构：
[1] CATHOLIC UNIV LEUVEN,FAC FARM WETENSCHAPPEN,LAB FARMACEUT CHEM ANAL GENEESMIDDELEN,B-3000 LOUVAIN,BELGIUM
[2] INST SALUD CARLOS III,CTR NATL FARMACOBIOL,E-28220 MAJADAHONDA,MADRID,SPAIN
来源：
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 1996年 / 14卷 / 05期
关键词：
ampicillin; assay; related substances test; purity; liquid chromatography;
D O I：
10.1016/0731-7085(95)01661-9
中图分类号：
O65 [分析化学];
学科分类号：
070302 ; 081704 ;
摘要：
Two laboratories collaborated to examine the selectivity of four isocratic liquid chromatography (LC) methods for the separation of ampicillin and its related substances. The United States Pharmacopeia (USP) assay method gave the best selectivity. Similar selectivity was obtained on C18 columns as well as on C8 and poly(styrene-divinylbenzene) copolymer columns. A resolution test using cefradine was proposed to replace the test with caffeine prescribed by the USP. Based on the USP method, a gradient LC method was developed for the analysis of related substances in ampicillin. This LC method has been proposed for assay and purity control in the ampicillin monographs of the European Pharmacopeia.
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收藏
页码：631 / 639
页数：9
相关论文
共 25 条
[1]   STABILITY OF AZTREONAM AND AMPICILLIN-SODIUM SULBACTAM SODIUM IN 0.9-PERCENT SODIUM-CHLORIDE INJECTION [J].
BELLIVEAU, PP ;
NIGHTINGALE, CH ;
QUINTILIANI, R .
AMERICAN JOURNAL OF HOSPITAL PHARMACY, 1994, 51 (07) :901-904
[2]   PIPERAZINEDIONE FORMATION FROM REACTION OF AMPICILLIN WITH CARBOHYDRATES AND ALCOHOLS IN AQUEOUS-SOLUTION [J].
BUNDGAARD, H ;
LARSEN, C .
INTERNATIONAL JOURNAL OF PHARMACEUTICS, 1979, 3 (01) :1-11
[3]   POLYMERIZATION OF PENICILLINS .4. SEPARATION, ISOLATION AND CHARACTERIZATION OF AMPICILLIN POLYMERS FORMED IN AQUEOUS-SOLUTION [J].
BUNDGAARD, H ;
LARSEN, C .
JOURNAL OF CHROMATOGRAPHY, 1977, 132 (01) :51-59
[4]  
DASGUPTA V, 1981, CAN J PHARM SCI, V16, P61
[5]  
GRANT NH, 1966, CHEM ABSTR P19976D, V65
[6]  
HAGINAKA J, 1986, CHEM PHARM BULL, V34, P2239
[7]  
HEKSTER YA, 1979, PHARM WEEKBL SCI ED, V1, P95
[8]   POLYMERIZATION OF PENICILLINS .5. SEPARATION, IDENTIFICATION AND QUANTITATIVE-DETERMINATION OF ANTIGENIC POLYMERIZATION PRODUCTS IN AMPICILLIN-SODIUM PREPARATIONS BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY [J].
LARSEN, C ;
BUNDGAARD, H .
JOURNAL OF CHROMATOGRAPHY, 1978, 147 (JAN) :143-150
[9]   SPECIFIC HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC DETERMINATION OF AMPICILLIN IN BULKS, INJECTABLES, CAPSULES AND ORAL SUSPENSIONS BY REVERSE-PHASE ION-PAIR CHROMATOGRAPHY [J].
LAUBACK, RG ;
RICE, JJ ;
BLEIBERG, B ;
MUHAMMAD, N ;
HANNA, SA .
JOURNAL OF LIQUID CHROMATOGRAPHY, 1984, 7 (06) :1243-1265
[10]   ISOLATION AND IDENTIFICATION OF A FLUOROPHORE FROM AMPICILLIN DEGRADATION [J].
LEBELLE, MJ ;
VILIM, A ;
WILSON, WL .
JOURNAL OF PHARMACY AND PHARMACOLOGY, 1979, 31 (07) :441-443
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