Development and validation of an reversed-phase liquid chromatographic method for analysis of spiramycin and related substances

被引:21
作者
Chepkwony, HK [1 ]
Vermaelen, A [1 ]
Roets, E [1 ]
Hoogmartens, J [1 ]
机构
[1] Katholieke Univ Leuven, Fac Farm Wetenschappen, Lab Farmaceut Chem & Anal Geneesmiddelen, B-3000 Louvain, Belgium
关键词
column liquid chromatography; spiramycin; factorial design; robustness;
D O I
10.1007/BF02491832
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
A simple, robust, sensitive isocratic liquid chromatographic (LC) method suitable for the analysis of spiramycin is described. This method utilizes XTerra RP18 as the stationary phase and acetonitrile-0.2 M K2HPO4 (pH 6.5)-water, 39.5:5:55.5 (v/v), as mobile phase. The mobile phase flow rate is 1.0 mL min(-1); the column is maintained at 70 degreesC by immersion in a water-bath; and UV detection is performed at 232 nm. The method has good selectivity towards the major components (spiramycins I, II, and III), other related substances, and many impurities. The robustness of the method was evaluated by means of full-factorial experimental design.
引用
收藏
页码:51 / 56
页数:6
相关论文
共 17 条
[1]  
BRYSKIER A, 1993, MACROLIDES CHEM PHAR, P12
[2]   OPTIMIZATION OF THE SEPARATION OF ERYTHROMYCIN AND RELATED SUBSTANCES BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY [J].
CACHET, T ;
KIBWAGE, IO ;
ROETS, E ;
HOOGMARTENS, J ;
VANDERHAEGHE, H .
JOURNAL OF CHROMATOGRAPHY, 1987, 409 :91-100
[3]   Liquid chromatography of troleandomycin [J].
Chepkwony, HK ;
Roets, E ;
Hoogmartens, J .
JOURNAL OF CHROMATOGRAPHY A, 2001, 914 (1-2) :53-58
[4]  
Chepkwony HK, 2001, CHROMATOGRAPHIA, V53, P159
[5]   Liquid chromatographic determination of erythromycins in fermentation broth [J].
Chepkwony, HK ;
Dehouck, P ;
Roets, E ;
Hoogmartens, J .
CHROMATOGRAPHIA, 2001, 53 (1-2) :89-92
[6]  
*COUNC EUR, 2000, EUR PHARM
[7]  
DOLAN JW, 2000, LC GC EUR, V13, P220
[8]   AUTOMATED HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC DETERMINATION OF SPIRAMYCIN BY DIRECT INJECTION OF PLASMA, USING COLUMN-SWITCHING FOR SAMPLE CLEANUP [J].
DOW, J ;
LEMAR, M ;
FRYDMAN, A ;
GAILLOT, J .
JOURNAL OF CHROMATOGRAPHY, 1985, 344 (NOV) :275-283
[9]  
GONZALEZ RH, 1999, J ELECTROPHORESIS, V20, P2407
[10]  
HORIE M, 1988, BUNSEKI KAGAKU, V37, P580