反相高效液相色谱法测定注射用维生素B6中有关物质  

Determination of Relevent Substances in Vitamin B6 for Injection by RP-HPLC

作　　者：刘放[1] 孙洁胤[1] 周芝芳[1] 

机构地区：[1]浙江省医学科学院药物研究所,杭州310013

出　　处：《浙江省医学科学院学报》2007年第1期10-12,共3页

摘　　要：目的建立了注射用维生素B6中有关物质的检测方法。方法采用反相高效液相色谱法，HypersiL C18柱（4．6，250mm，10mm），流动相：磷酸二氢钾庚烷磺酸钠溶液（取磷酸二氢钾13．6g与庚烷磺酸钠1．0g，加水溶解并稀释成1000mL）-甲醇-三乙胺（85：15：0．4）用磷酸调pH值至2．8。检测波长：291nm。结果维生素B6及其有关物质得到基线分离，最低检测量为0．05ng，控制总杂质量不得过1．0％。结论本法简便、快速、准确，适用于维生素B6及其制剂的质量控制。Objective To establish a method for the control of relevent substances in vitamin B6 for injection. Methods A RP-HPLC method was developed. Chromatographic conditions inclocded a hypersil C1s colunm with the mobile phase of potassium phosphate monebosic-1-hexane-sulfonic acid sodium salt sohion （potassium phosphate monebosic 13.6g and 1-hexanesulfonic acid sodium salt 1.0g in water to 1000mL） and methanol - triethylamine （85：15：0.4）, pH 2.8 was adjusted with phosphoric acid. The UV detection wavelength was set up at 291nm. Results The peak of vitamin and its relevent substances were separated completely. The LOD was 0.05ng. Conclusion The method was simple, rapid and accurate and can be used to control vitamin B6 for injection and its preparations.

关 键 词：注射用维生素B6 有关物质 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]