应用比浊法测定低分子肝素钠的含量

Determination of low molecular weight heparin sodium by turbidimetric method

目的:建立一种测定低分子肝素钠(LMWH)含量的方法。方法:通过LMWH与氯化十六烷基吡啶(CPC)反应产生沉淀形成混悬液,采用分光光度计于波长680nm处比浊,研究LMWH浓度与吸收度的线性关系,并研究本方法测定LMWH的稳定性、重现性和回收率。结果:在一定pH值和离子强度下,LMWH在12.5～250μg/ml浓度范围内与CPC反应生成的混悬液在波长680nm处的吸收度与其浓度呈线性关系,r=0.9991;本方法在1～3h内吸收度保持稳定(RSD=0.142%,n=9),LMWH测定浓度为40、100和160μg/ml时的平均回收率分别为98.63%、99.40和100.76%,RSD分别为0.34%、0.16%和0.19%。结论:应用比浊法测定LMWH的含量方便、简捷、重现性好,可用于质量监控。

Objective:To establish a method for the determination of low molecular weight hep-arin sodium(LMWH).Methods :A turbid solution was formed through the reaction between LMWH and cetylpyridinium chloride(CPC)and the turbidity was measured by using ultraviolet-visible spec-troscopy at680nm.The linearity between the concentration of LMWH and its absorbance,the stability,repeatability and the recovery of the method were studied.Results:Through the reaction of LMWH with CPC,a homogeneous turbid solution wa s formed.The turbid solution was stable from1to3h.Under proper pH value and ion strength,the absorbance of the solution at680nm had a good linear rela-tionship with the concentration of LMWH in the range of12.5～250μg /ml,r=0.9991.The recovery was within the range of98.63%～100.76%(n=5).The relative standard divisions of the method for determin-ing LMWH at the concentrations of40,100and160μg /ml were0.34%,0.16%and0.19%respectively.Con clu sion:The turbidimetric method has advantages of convinience,simplicity and good repeatability and can be used to control the quality of LMWH and its products.