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 .
出处
《西北药学杂志》
CAS
2014年第6期589-592,共4页
Northwest Pharmaceutical Journal
