两种方法测定硫酸庆大霉素组分和有关物质的比较
Comparison of determination of the components and related substances in Gentamicin by two HPLC methods
刘英 1王立萍1
作者信息
- 1. 河南省食品药品检验所,河南郑州450003
- 折叠
摘要
目的 采用《中国药典》2010年版和BP2012中收载的两种测定方法,测定硫酸庆大霉素中的组分及其有关物质并进行比较.方法 采用两国药典方法分别测定硫酸庆大霉素及其注射液中的组分和有关物质,并进行方法专属性、灵敏度、溶液稳定性和耐用性的比较.结果 BP2012中收载的离子色谱法(HPLC-IPAD)与《中国药典》2010年版中收载的HPLC-ELSD法所测定组分的结果一致;HPLC-IPAD法虽然比较灵敏,但HPLC-ELSD的进样量更大,可检测到更多的有关物质.结论 《中国药典》中的HPLC-ELSD法简便、实用,可用于硫酸庆大霉素原料及其制剂的质量控制.
Abstract
OBJECTIVE To compare the analytical methods for the components and related substance in Gentamicin in Chinese Pharmacopoeia 2010 edition and British Pharmacopoeia 2012 edition.METHODS The components and its related substances in Gentamicin were analyzed using the methods in two Pharmacopoeia.The evaluation was made between the two methods by application of the specificity,sensitivity,solution stability and ruggedness,the components in Gentamicin and its related substances of sulfate Gentamicin and its injection were analyzed.RESULTS The results of the components in Gentamicin and its related substances by the two different methods were same,and also the HPLC-IPAD method in BP2012 was sensitive.However,the HPLC-ELSD method in ChP 2010 could bear higher weight,so the HPLC-ELSD method could determine more impurities.CONCLUSION The HPLC-ELSD method in ChP2010 edition is relatively simple and practical to analyze the components in Gentamicin and related substances at present.
关键词
离子色谱法/积分脉冲安培检测器/高效液相色谱蒸发光散射检测法/庆大霉素/组分/有关物质Key words
Ion chromatography (IC)/IPAD/HPLC-ELSD/Gentamicin/Component/Related substances引用本文复制引用
出版年
2014
NETL
NSTL
维普
万方数据