CAJ | 학술논문

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。
목적：건립린매소개구복제제중이지잡질화미지잡질검측방법。방법채용 Apllo C18색보주（250 mm ×4．6 mm ，5μm），이5 mmol ? L -1정신알（용작산조 pH4．8）-을정（90∶10）위류동상，채용증발광검측기。결과린매소개검출한위6．82 ng ，재20．2～121．2μg 선성범위내정량호적선성관계，상관계수 r ＝0．9992（n＝6）。결론해방법조작간단，중복성호，검측결과준학，능경호지공제린매소개구복제제중잡질적함량。
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 .