HPLC法测定注射用氟氯西林钠氨苄西林钠的含量及有关物质  

Determination of flucloxacillin sodium and ampicillin for injection by HPLC

作　　者：邢亮彬[1] 张菁[1] 高燕霞[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》2006年第7期414-416,共3页Chinese Journal of Antibiotics

摘　　要：目的建立注射用氟氯西林钠氨苄西林钠含量的HPLC测定方法。方法使用C18柱,以磷酸二氢钾(0.1mol/L)∶十二烷基硫酸钠(0.012mol/L)∶甲醇∶乙腈(280∶300∶200∶220)(用磷酸调pH值至2.8)为流动相,检测波长为225nm。结果氟氯西林钠与氨苄西林钠的线性范围均为0.03～0.60mg/ml,r均为0.9999。氟氯西林平均加样回收率为99.9%,RSD为0.6%(n=9);氨苄西林钠平均加样回收率为99.9%,RSD为1.2%(n=9)。结论该方法简便、准确、灵敏度高,同时对产品中的有关物质能进行准确控制。林;Objective To establish a method for the determination of flucloxacillin sodium and ampicillin sodium for injection by HPLC. Method A C18 was used. The mobile phase was KH2PO4（0.1mol/L） ： SDS （0. 012mol/L）： methanol： acetonitrile（280： 300： 200： 220）, pH was adjusted to 2.6 using phosphoric acid. The wavelength of UV detector was 225nm. Results The average recovery of flucloxacillin was 99.9% （RSD = 0. 6%, n = 9）, and the average recovery of ampicillin was 99. 9% （RSD = 1.2%, n = 9）. Conclusion The method was convenient and accurate, could be used to monitor and control the related substances in the product. The influence of the mobile phase pH on resolution of flucloxacillin and the related substances cloxacillin was also investigated.

关 键 词：氟氯西林 氨苄西林 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]