离子对高效液相色谱法测定注射用美洛西林钠—舒巴坦钠含量

目的：建立反相离子对高效液相色谱法测定注射用美洛西林钠－舒巴坦钠含量。方法：采用μＢｏｎｄａｐａｋＣ１８色谱柱，０００５ｍｏｌ·Ｌ－１氢氧化四丁基铵－乙腈（６８∶３２，ｐＨ５０±０１）为流动相，２３０ｎｍ为检测波长，３０℃柱温下对美洛西林和舒巴坦进行分离和测定。结果：能同时测定制剂中美洛西林和舒巴坦的含量。美洛西林在０２５～１５ｍｇ·ｍＬ－１，舒巴坦在０１２５～０７５ｍｇ·ｍＬ－１范围内，峰面积与其浓度呈良好线性关系（ｒ＝０９９９９）；平均回收率（ｎ＝５）美洛西林为９９７６％（ＲＳＤ＝０９２％），舒巴坦为９９６６％（ＲＳＤ＝０８５％）。结论：该法简便、快速、准确，适用于该药品生产及临床应用中的质量监控。

Determination of Content of Mezlocillin Sodium-Sulbactam Sodiumfor Injection by Ion Pair High Performance Liquid Chromatography

Objective: To establish a method using reversed-phase ion pair high performance liquid chromatography,for determining the content of mezlocillin sodium-sulbactam sodium for injection. Methods: Mezlocillin and sulbactam were separated and determinated on LC-3A HPLC instrument used a Bondapak C18 column(25 cm46 mm,10 m),the mobile phase consisted of 0005 molL-1 tetrabutylammonium hydroxide-acetonitrile(6832,pH 5001)and the flow rate was 08 mLmin-1.The column temperature was 30 and the UV detection wavelength was 230 nm. Results: It can simultaneously determine the content of mezlocillin and sulbactam in the drug preparation.The calibration curves were linear in the range of 02515 mgmL-1 for mezlocillin(r=09999)and 0125075 mgmL-1 for sulbactam(r=09999).The average recoveries(n=5)of mezlocillin and sulbactam were 9976 %(RSD=092 %)and 9966 %(RSD=085 %),respectively.ZConclusion: This method is simple,quick and accurate and is very suitable for the quality control the drug preparation factory and clinical