梯度洗脱HPLC法测定盐酸平阳霉素及注射药物中的有关物质  

Determination of related substances in bleomycin A5 hydrochloride by gradient elution HPLC

作　　者：杨倩[1] 吴燕[1] 袁雯玮[1] 米亚娴[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《中国抗生素杂志》2009年第8期481-484,共4页Chinese Journal of Antibiotics

摘　　要：目的建立梯度洗脱HPLC法测定盐酸平阳霉素及注射用盐酸平阳霉素中的有关物质。方法采用C18(150mm×4.6mm,5μm)色谱柱,己烷磺酸钠溶液(己烷磺酸钠7.53g与乙二胺四乙酸二钠3.72g以0.08mol/L乙酸溶液溶解并稀释至1000ml,用氨溶液调节pH为4.3)为流动相A,甲醇∶乙腈(70∶30)为流动相B,梯度洗脱,流速1.0ml/min,检测波长254nm,柱温30℃。结果盐酸平阳霉素溶液在10～500μg/ml范围内,溶液浓度与峰面积呈良好线性关系,r=0.9999;最低检测浓度1μg/ml。结论本法可用于测定盐酸平阳霉素及注射用盐酸平阳霉素中的有关物质。Objective To establish a gradient elution HPLC method to determine the related substances of bleomycin A5 hydrochloride. Method A C18 （150mm × 4.6mm,5μm）column was used. The mobile phase consisted of sodium hexane sulfonate and EDTA-2Na （pH4.3 ,adjusted with ammonia）as mobile phase A and methanol： acetonitrile （70：30） as mobile phase B. Gradient elution was used. The flow rate was 1.0ml/min. The detection wavelength was 254nm. The column temperature was 30℃. Results The calibration curve was linear in the range of 10 - 500μg/ml for bleomycin A5 hydrochloride （ r = 0.9999 ）. The minimal detection limit was 1 μg/ml. Conclusions The selective and reliable method can be used for determination of related substances in bleomycin A5 hydrochloride.

关 键 词：盐酸平阳霉素 梯度洗脱HPLC法 有关物质 

分 类 号：R978.1[医药卫生—药品]