HPLC-ELSD法测定盐酸乙胺丁醇片的含量及溶出度  

HPLC-ELSD determination of content and dissolution of ethambutol hydrochloride tablets

作　　者：柳小秦 吴少平 李霞 李继 宋燕玲 

机构地区：[1]陕西省药品检验所,西安710061

出　　处：《药物分析杂志》2008年第5期804-806,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:采用 HPLC-ELSD 法建立了盐酸乙胺丁醇片含量及溶出度的测定方法。方法:采用 Kromasil C_(18)(250 mm×4.6mm,5μm)色谱柱,流动相:乙腈-水(50:50),流速:0.6 mL·min^(-1),柱温:20℃。蒸发光散射检测器条件为:撞击器状态:关,漂移管温度:105℃,载气流速:2.6 L·min^(-1)。结果:盐酸乙胺丁醇浓度在64～640μg·mL^(-1)的范围内呈良好的线性关系(r=0.9992);平均加样回收率(n=6)为99.4%,RSD 为0.7%。结论:本方法操作简便、准确、稳定,灵敏度高,适用于盐酸乙胺丁醇片质量控制。Objective： To establish an HPLC - ELSD method for determination of content and dissolution of ethambutol hydrochloride tablets. Methods： The chromatographic condition was as follows： Kromasil C18 （250 mm × 4. 6 mm,5 μm） , the mobile phase was composed of acetonitrile - water （ 50：50 ） , flow rate was 0.6 mL · min^ - 1, column temprature was 20 ℃ ;The condition of ELSD was as follows：impactor was off,drift tube was at 105℃ ,flow rate was 2. 6 L · min^-1. Results： The calibration curves showed good linearity in the range of 64 -640 μg · mL^-1 （r = 0. 9992 ） ;The average recovery rate（ n =6 ）was 99. 4% （RSD = 0. 7% ）. Conclusion：The method is good in the aspect of reproducibility and sensitivity. It can be applied for the quality control of ethambutol hydrochloride tablets.

关 键 词：HPLC-ELSD 盐酸乙胺丁醇片 含量测定 溶出度 

分 类 号：R917[医药卫生—药物分析学]