柱前衍生-反相高效液相色谱测定牛磺罗定及固体制剂含量

Determination of Taurolidine by Pre-column Derivatization and Reversed-Phase High Performance Liquid Chromatography

本文建立了对甲苯磺酰氯柱前衍生-反相高效液相色谱紫外检测法测定牛磺罗定及其固体制剂含量的方法。利用牛磺罗定中含有仲胺基的特点,以对甲基苯磺酰氯柱前衍生牛磺罗定,Venusil XBP C18色谱柱分离,在240nm波长检测,线性范围为0.016～0.160g.L-1(r=0.9995),衍生化产物在24h内稳定,相对标准偏差(RSD)为3.8%,回收率为98.5%～101.2%。本方法简便、灵敏度高,且对检测设备要求低,适用于工业生产中大批量牛磺罗定原料药及其固体制剂的含量测定。

A method using pre-column derivatization and reserved-phase high performance liquid chromatography（RP-HPLC） UV detection was developed to determine taurolidine.Taurolidine was derivated with p-toluenesulfonyl chloride and then separated by Hypersil ODS C18 column,and detected under the 240 nm wavelength.The linear range of taurolidine was from 0.016 to 0.160 g/L with the recoveries from 98.5% to 101.2%.Derivative products were relatively stable during 24 h（RSD=3.8%）.The method was simple,convenient,sensitive and required low-cost detection device,which is possibly more suitable for the determination of industrial production of taurolidine and in its solid dosage forms.