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

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

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 -C1 8(10 μm ,4 5mm× 15 0mm)色谱柱 ,以乙腈 -水 (4 5∶5 5 ,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 2 30nm。结果 :本法可同时测定 4种组分的含量。盐酸利多卡因在 13～ 6 4μg·mL- 1 、地塞米松在 4 5～ 38μg·mL- 1 、卡巴芬乙酸 (钠盐 )在 2 6 9～ 16 14μg·mL- 1 、保泰松钠在 40 2～ 2 0 77μg·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 % ) ,10 1 0 % (RSD =0 4% ) ,10 0 5 % (RSD =0 2 % ) ,10 0 6 % (RSD =0 8% )。结论 :方法简便、快速、准确 ,可作为样品的检测方法。

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-C 18(45 mm×150 mm,10 μm)column,the mobile phase consisted of 25 mmol·mL -1 cetyltrimethylammonium bromide-acetonitrile(55∶45),at a flow rate of 15 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,45～38 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 999%(RSD=12%),1010%(RSD=04%),1005%(RSD=02%),1006%(RSD=08%).Conclusion:This method is simple,fast and accurate.