反相离子对高效液相色谱法测定泰必治注射液A中4种组分的含量

摘　要：目的：采用反相离子对高效液相色谱法测定泰必治注射液A中盐酸利多卡因、地塞米松、卡巴芬乙酸(钠盐)与保泰松钠4种组分的含量。方法：采用YWG-C₁₈(10μm,4.5mm×150mm)色谱柱，以乙腈-水(45∶55，含2.5mmol.L-1十六烷基三甲基溴化铵)为流动相，流速1.5mL^.min^-1，柱温40℃，检测波长230nm。结果：本法可同时测定4种组分的含量。盐酸利多卡因在13～64μg^.mL^-1、地塞米松在4.5～38μg^.mL^-1、卡巴芬乙酸(钠盐)在269～1614μg^.mL^-1、保泰松钠在402～2077μg^.mL^-1范围内，峰面积与其浓度呈良好的线性关系；平均回收率(n=5)依次为99.9%(RSD=1.2%)，101.0%(RSD=0.4%)，100.5%(RSD=0.2%)，100.6%(RSD=0.8%)。结论：方法简便、快速、准确，可作为样品的检测方法。

关键词：泰必治　盐酸利多卡因　地塞米松　卡巴芬乙酸(钠盐)　保泰松钠　反相离子对高效液相色谱法

分类号：R927　文献标识码：A

Determination of Content of Four Components for Trabit Injection A by Reverse-Phase Ion Pair HPLC

HAN Cheng-hua（Xining Institute for Drug Control,810007）　
NIE Xiao-chun（Wuhan Institute for Drug Control,430012）　

Abstract：Objective：To establish a method using reverse-phase ion pair HPLC,for determining the content of four components―lidocaine hydrochloride,dexamethasone,o-carbamoylphenoxyacetic acid(sodium salt),phenylbutazone sodium of trabit injection A.Method:Used a YWG-C₁₈(4.5 mm×150 mm,10 μm)column,the mobile phase consisted of 2.5 mmol^.mL^-1 cetyltrimethylammonium bromide-acetonitrile(55∶45),at a flow rate of 1.5 mL^.min^-1.The column temperature was 40 ℃ and UV detection wavelength was 230 nm.Results:The contents of four components can be simultaneously determined.The calibration curves were linear in the range of 13～64 μg^.mL^-1 for lidocaine hydrochloride,4.5～38 μg^.mL^-1 for dexamethason,269～1 614 μg^.mL^-1 for o-carbamoylphenoxyacetic acid(sodium salt),402～2 077 μg^.mL^-1 for phenylbutazone sodium respectively.The average recoveries of the four components above respectively were 99.9%(RSD=1.2%)，101.0%(RSD=0.4%),100.5%(RSD=0.2%),100.6%(RSD=0.8%).Conclusion:This method is simple,fast and accurate.
Keywords：trabit,lidocaine hydrochloride,dexamethasone,o-carbamoylphenoxyacetic acid(sodium salt),phenylbutazone sodium,reverse-phase ion pair HPLC

参考文献：

［1］ZHANG Xin-zhong(张新中).The High Performance Liquid Chromatography Analysis(高效液相色谱分析).Beijing Academic Journal Publishing House(北京学术刊物出版社),1989.129(in Chinese)

收稿日期：2000年12月5日

出版日期：2001年3月31日