摘要
目的对中国药典2010版和美国药典34版中头孢地尼有关物质的分析方法进行比较和优化。方法采用两国药典方法分析头孢地尼的有关物质,通过理论塔板数、分离度等参数进行方法评价;运用色谱相关光谱法技术对两种方法分离的头孢地尼有关物质进行相互识别;调整流动相比例,进行分析方法优化。结果中国药典2010版方法的分离能力优于美国药典34版;由色谱相关光谱法分析可知,两种方法中头孢地尼有关物质的洗脱顺序一致;优化后方法还能有效分离降解杂质反式头孢地尼和反应中间体乙酰化头孢地尼。结论优化后的头孢地尼有关物质分析方法的分离能力优于ChP2010版和USP34版方法,能有效对头孢地尼的有关物质进行控制。
Objective To compare and optimize the analytical method for cefdinir related substance in Chinese Pharmacopoeia 2010 edition and United States Pharmacopoeia 34 edition. Methods Cefdinir and its related substances wife analyzed using methods in two Pharmacopoeia; an evaluation was made between the two methods by application of the theoretical plate number and resolution parameters; two dimensional chromatographic correlation spectroscopy technique was applied to identify cefdinir related substances detected in two different methods; analytical method was further optimized by adjusting the gradient elution system. Results The separation ability of method in ChP 201 f edition is superior to USP 34; chromatographic correlation spectroscopy technique showed that cefdinir related substances had the same retention behavior when analyzed by the two different methods; the degradation impurity anti-cefdinir and synthesis intermediate acetyl cefdinir was effectively separated by the optimized method. Conelusiol The separation capability of optimized method is superior to ChP2010 edition and USP34, which is suitable for the quality control of cefdinir related substances.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2012年第8期610-614,627,共6页
Chinese Journal of Antibiotics
基金
国家重大新药创制专项课题"微生物药物技术创新与新药创制产学研联盟"的资助
课题编号2010ZX09401
关键词
二维色谱相关光谱技术
头孢地尼
头孢菌素
有关物质
Chromatographic correlation spectroscopy technique
Cefdinir
Cephalosporin
Related substances
