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HPLC法测定复方岩白菜素片中两组份含量及马来酸氯苯那敏的含量均匀度
引用本文:蒋学珍,丁雄,杨怀镜. HPLC法测定复方岩白菜素片中两组份含量及马来酸氯苯那敏的含量均匀度[J]. 中国民族民间医药杂志, 2011, 20(4): 36-37
作者姓名:蒋学珍  丁雄  杨怀镜
作者单位:蒋学珍,JIANG Xue-zhen(云南省怒江州疾病预防控制中心,云南,泸水,673100);丁雄,DING Xiong(云南中医学院,云南,昆明,650500);杨怀镜,YANG Huai-jing(云南省大理州食品药品检验所,云南,大理,671000)
摘    要:采用HPLC法测定复方岩白菜素片的含量及含量均匀度,选用VP—ODSC18色谱柱,甲醇-1%醋酸溶液(用三乙胺调节PH至3.7±0.1)为流动相作梯度洗脱;检测波长260nm。岩白菜素在1.13~18.08μg的范围内呈良好的线性关系,1=0.9999,平均回收率为100.1%(n=5),RSD=1.81%;马来酸氯苯那敏在0.02~0.36μg的范围内呈良好的线性关系,^r=0.9999,平均回收率为98.5%(n=5),RSD=1.32%。本法操作简便准确,测定复方岩白菜素片两组份含量及马来酸氯苯那敏含量均匀度,便于全面控制制剂的质量。

关 键 词:复方岩白菜素片  高效液相色谱法  含量  含量均匀度

HPLC Determination of Content and Content Uniformity of Chlorphenamine Maleate of Compound Bergeninum Tablets
JIANG Xue-zhen,DING Xiong,YANG Huai-jing. HPLC Determination of Content and Content Uniformity of Chlorphenamine Maleate of Compound Bergeninum Tablets[J]. Chinese Journal of Ethnomedicine and Ethnopharmacy, 2011, 20(4): 36-37
Authors:JIANG Xue-zhen  DING Xiong  YANG Huai-jing
Affiliation:JIANG Xue-zhen1,DING Xiong2,YANG Huai-jing3(1.Nujiang Center for Disease Control and Prevention,Yunnan Province,673100,2.Yunnan University of Traditional Chinese Medicine,650500,3.Dali Prefecture Institute for Food and Drug Control,671000)
Abstract:A HPLC method for the determination of Bergninum and chlorphenamine Maleate and content uniformity in Compound Bergeninum Tablets was established. VP - ODS C18 column was used, the mobile phase was composed of methanol - 1% Acetic Acide (adjusted to PH3. 7 ±0. 1 by diethylamine) with a gradient elution, detection wavelength is 260nm. The liner correlation was good in the range of 1.13 - 18.08μg of Bergninum ( r=0. 9999), the average recovery was 100. 1% ( n = 5) and the relative standard diviation was 1.81% ; The liner correlation was good in the range of 0. 02 ~0. 361μg of Chlorphenamine Maleate (n=0. 9999), the average recovry was 98. 5% (n =5) and the relative standard diviation was 1.32%. The method is simple, accurate and can be used for quality control of Compound Bergeninum Tablets.
Keywords:Compound Bergeninum Tablets  HPLC  Content  Content Uniformity  
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