葡聚糖凝胶柱层析法分离测定注射用阿洛西林钠中的聚合物  

Separation and determination of the polymer in mezlocillin sodium for injection by glucose gel column chromatography

作　　者：薛萍 强双畅[2] 刘晓瑜 

机构地区：[1]江苏无锡药品检验所,无锡214021 [2]中国药科大学,南京211198

出　　处：《海峡药学》2010年第3期39-41,共3页Strait Pharmaceutical Journal

摘　　要：目的建立一种利用葡聚糖凝胶柱分离测定注射用阿洛西林钠中聚合物的方法。方法注射用阿洛西林钠中的高分子杂质的定量测定是利用葡聚糖凝胶柱色谱法。色谱柱:XK16/40SephadexG-10,柱长:35cm;流动相A为pH7.0,0.025mol.L-1磷酸盐缓冲液,流动相B为超纯水,流速:1.5mL·min-1,检测波长254nm,进样量200μL。结果注射用阿洛西林钠在浓度为5.0～60mg.mL-1的范围内与其峰面积呈良好的线性关系(r为0.9990)。结论本法用于注射用阿洛西林钠中的高分子杂质的测定,灵敏度高,准确性好。OBJECTIVE To establish a Glucose gel column method for the separation and determination of the polymer in Mezlocillin sodium for injection.METHODS Quantification of high molecular weight impurities in cefepime mezlocillin sodium for injection was determined by Glucose gel column chromatography.The mobile phase consisted of 0.025 mol·L^-1 phosphate buffer（pH7.0）and supper pure water.and detection wave length 254nm.RESULTS The calibration curve was linear in t he concentration range of 5.0～60 mg·mL^-1（r=0.9990）.CONCLUSION This method was sensitive and accurate for determining high molecular weight impurities in Mezlocillin Sodium for Injection

关 键 词：注射用阿洛西林钠 葡聚糖凝胶 聚合物 

分 类 号：R927.2[医药卫生—药学]