摘要
为了建立气相色谱法测定鼻炎康片中马来酸氯苯那敏的含量,采用HP-5MS毛细管柱经程序升温技术分离待测组分,外标法计算含量,进样口温度：270℃;FID检测器,检测器温度300℃;进样量1μL。马来酸氯苯那敏在0.01~0.1 mg/m L（相关系数r=0.999 9）范围内呈良好线性关系,实验仪器精密度良好（RSD=0.199%）,重复性好（RSD=0.46%）,实验稳定性良好,平均加样回收率为98.4%（RSD=0.503%,n=9）。方法灵敏度高,重现性好,专属性强,且操作简便,可用于鼻炎康的质量控制。
To establish a new method for determinating the content of Chlorphenamine maleate in Biyankang tablets through GC, the HP-5 quartz capillary column with processing temperature rising was used to separate the analyte and the external standard method was used to calculate the content of maleic acid with the inlet temperature of 270 ℃ ,a FID ,the detector temperature of 300℃ and the injection volume of 1μL The results reveal that the components separation is good, the Cblorpbenamine maleate content in the range from 0. 01 - 0. 1 mg/mL （ r = 0. 9999 ） shows good linear relationship, the precision of the experimental instrument is good （RSD = 0. 199% ）, good reproducibility （RSD = 0. 46% ）, experimental stability is good and the average recovery rate of chlorphena-mine maleate was 98. 4% （ RSD = 0. 503% , n = 9 ）. The GC method was highly repeatable, highly sensitive and specific, and simple, so it can be used for quality control of Biyankang.
作者
梁凤兰
黄政贵
LIANG Feng-Lan HUANG Zheng-Gui(Life Science School, Zhaoqing University, Zhaoqing 526061, China Zhanfiang Institute for Food and Drug Control, Zhanjiang 524022, China)
出处
《药物生物技术》
CAS
2016年第6期515-518,共4页
Pharmaceutical Biotechnology
关键词
气相色谱法
鼻炎康片
马来酸氯苯那敏
含量测定
外标法
质量控制
GC, Biyankang tablets,Chlorphenamine maleate, Determination of content, External standard method, Quality control
