磷霉素钙口服制剂有关物质测定方法的建立  

Establishment of determination method for the related substance in Oral Preparation of Fosfomycin Calcium

作　　者：刘雪峰[1,2] 樊宝娟[1,2] 王小亮 曾爱国[1] 常春[1] 傅强[1] 

机构地区：[1]西安交通大学药学院,西安710061 [2]陕西省食品药品检验所,西安710065

出　　处：《西北药学杂志》2014年第6期589-592,共4页Northwest Pharmaceutical Journal

摘　　要：目的：建立磷霉素钙口服制剂中已知杂质和未知杂质检测方法。方法采用 Apllo C18色谱柱（250 mm ×4．6 mm ，5μm），以5 mmol·L^-1正辛胺（用醋酸调 pH4．8）-乙腈（90∶10）为流动相，采用蒸发光检测器。结果磷霉素钙检出限为6．82 ng ，在20．2～121．2μg 线性范围内呈良好的线性关系，相关系数r＝0．9992（n＝6）。结论该方法操作简单，重复性好，检测结果准确，能更好地控制磷霉素钙口服制剂中杂质的含量。Objective To establish a method to detect the known and unknown impurities in Oral Preparation of Fosfomycin Calci-um .Methods The HPLC analysis was performed on a Apllo C18 （250 mm × 4 .6 mm ,5 μm） column ,the mobile phase consisted of 5 mmol ？ L - 1 octyl amine （used acetic acid adjust pH to 4 .8） and acetonitrile（90 ∶ 10） ,and the detector was ELSD .Results The limit of detection of fosfomycin calcium was 6 .82 ng ,and good linear relationship were obtained in the range of 20 .2-121 .2 μg ,r =0 .999 2（n= 6） .Conclusion The method is simple ,repeatable ,accurate and can be used for the quality control of the Oral Prepara-tion of Fosfomycin Calcium .

关 键 词：磷霉素钙 有关物质 高效液相色谱法 口服制剂 

分 类 号：R917[医药卫生—药物分析学]