梯度洗脱HPLC法测定苄星青霉素中的有关物质  

Determination of related substances of benzathine benzylpenicillin by gradient elution HPLC method

作　　者：陈汝红[1] 

机构地区：[1]河北省药品检验所,石家庄050011

出　　处：《中国抗生素杂志》2012年第3期223-226,共4页Chinese Journal of Antibiotics

基　　金：河北省科研指导计划(No.06276425)

摘　　要：目的建立测定苄星青霉素有关物质的梯度洗脱HPLC法。方法采用端基封尾的C18柱,流动相A为0.05mol/L磷酸二氢钾溶液(用磷酸调节pH值至3.1),流动相B为甲醇,流速1.0mL/min,线性梯度洗脱,检测波长220nm,柱温40℃。结果二苄基乙二胺和青霉素分别与相邻杂质峰分离完全,二苄基乙二胺的检测限为2.5ng,青霉素的检测限为0.6ng。结论本法专属、灵敏,可作为苄星青霉素有关物质的测定方法。Objective To develop gradient elution HPLC method for the determination of related substances in benzathine benzylpenicillin. Methods The HPLC method was carried on a column packed with end-capped octadecylsilance bonded silica gel, 0.05mol/L potassium dihydrogen solution （adjust pH to 3.1 with phosphoric acid ） as mobile phase A and methanol as mobile phase B, the flow rate was 1.0 mL per minute, linear gradient elution. The column temperature was 40℃. The detection wavelength was 220 nm. Results Benzathine and benzylpenicillin could be completely separated from the other impurities respectively. Limit of detection for benzathine was 2.5ng. Limit of detection for benzylpenicillin was 0.6ng. Conclusion The proposed HPLC method was specific and sensitive. The method could be used for the determination of related substances in benzathine benzylpenicillin.

关 键 词：苄星青霉素 有关物质 梯度洗脱HPLC法 

分 类 号：R978.11[医药卫生—药品]