文档介绍：高效液相色谱法测定注射用亚***培南西司他丁钠含量
摘要: 目的建立正相高效液相色谱法测定注射用亚***培南西司他丁钠的含量。方法色谱柱用***基柱(250 mm × mm ,5 μm),柱温30℃,流动相为乙***–%磷酸(50 :50),流速1mL/min,检测波长265 nm。结果亚***培南和西司他丁钠的理论板数分别约为9000和9500,。以峰面积(X)对进样浓度(Y,μg/mL)线性回归,亚***培南的回归方程:Y=+,,~ μg/mL;西司他丁钠的回归方程:Y=+,,~ μg/mL。亚***培南和西司他丁钠的回收率(RSD)%(%)%(%)。结论本方法精密度和准确度好,操作简便,可用于测定注射用亚***培南西司他丁钠中亚***培南和西司他丁钠的含量。
关键词:高效液相色谱法;亚***培南;西司他丁钠
中图分类号: 文献标识码:A 文章编号:2008-
Determination of Imipenem and Cilastin for Injection Sodium by HPLC
ABSTRACT: OBJECTIVE To establish an HPLC quantitative method for the determination of Imipenem and Cilastin Sodium for Injection . METHOD The chromatographic conditions column(250 mm × mm,5 μm) , temperature 30°C, acetonitrile–% phosphoric acid(50:50) as mobile phase . The flow rate was 1ml/min and monitored at 265 nm. RESULTS The theoretical plate number of Imipenem is 9000, and that of Cilastin Sodium is resolution is more than . The regress equation for Imipenem was Y=+ , r= and the linear range was ~;Cilastin Sodium Y=+, r=,and the linear range was ~ average recovery (RSD)of Imipenem , Cilastin Sodium were % (%) and %(%) respectively. CONCLUSIONS The method is precise, accurate, simple, and can be applied to determin the content of Imipenem and Cilastin Sodium for Injection.
KEY WORDS: HPLC ; Imipenem; Cilastin Sodium
注射用亚***培南西司他丁钠由β-内酰***类抗生素亚***培南和肾肽酶抑制剂西司他丁钠加碳酸氢钠为辅料混合而成,含量测定方法在USP29版[1]和国家食品药品监督管理局进口
作者简介:刘刚,男,副主任药师
Tel: ( 010)66356187 E-mail: ******@vip. 
*通讯作者:谭生建,男,主任药师
Tel: ( 010)66356172 E-mail: tansj163@
药品注册标准[2]有收载,也有方法改进研究的文献报道[3,4,5],都是采用反相高效液相色谱法,色谱条件如色谱柱、流动相组成、流动相pH值、检测波长等也相同,只是流速大小有所不同。迄今,注射用亚***培南西司他丁钠的含量测定方法仍存在一些不足[3,4,5],特别是亚***培南保留时间短( min ),与有关物质分离不够,使用单一水相做流动相,难以调整系统适用性是其主要的问题。本试验研究建立了正相高效液相色谱法测定注射用亚***培南西司他丁钠的含量。
仪器高效液相色谱仪(安捷伦公司Agilent 1200系列)包括:G1311A 四元色谱泵,G1329A自动进样器