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HPLC法测定感特灵胶囊中马来酸氯苯那敏的含量及含量均匀度
引用本文:马坤芳,都述虎,王德旺,季宏建.HPLC法测定感特灵胶囊中马来酸氯苯那敏的含量及含量均匀度[J].现代中药研究与实践,2005,19(5):41-43.
作者姓名:马坤芳  都述虎  王德旺  季宏建
作者单位:1. 南京医科大学药学院,江苏,南京,210029
2. 江苏省人民医院药剂科,江苏,南京,210029
摘    要:目的建立感特灵胶囊中马来酸氯苯那敏含量均匀度的测定方法。方法选择五批市售感特灵胶囊,采用Shim-Pack VP-ODS柱,以甲醇-0.05 mol.L-1磷酸二氢钠溶液-三乙胺(19∶81∶0.025)为流动相,检测波长为215 nm。结果马来酸氯苯那敏在0.116 4μg~0.349 2μg范围内呈良好线性关系(r=0.999 7,n=5),平均回收率为97.90%,RSD=2.83%;五批市售胶囊剂含量均匀度均不符合规定。结论此法简便、结果可靠,为感特灵胶囊的生产工艺改进提供参考。

关 键 词:感特灵胶囊  马来酸氯苯那敏  含量均匀度
文章编号:1004-2199(2005)05-0041-03
收稿时间:2005-08-20
修稿时间:2005年8月20日

Determination of Content and Uniformity of Chlorphenamine Maleate in Ganteling Capsules by HPLC
MA Kun-fang,DU Shu-hu,WANG De-wang,JI Hong-jian.Determination of Content and Uniformity of Chlorphenamine Maleate in Ganteling Capsules by HPLC[J].Research and Practice on Chinese Medicines,2005,19(5):41-43.
Authors:MA Kun-fang  DU Shu-hu  WANG De-wang  JI Hong-jian
Institution:MA Kun-fang~1,DU Shu-hu~1,WANG De-wang~2,JI Hong-jian~1
Abstract:Objective To develop a method for determining the content and uniformity of chlorphenamine maleate in Ganteling capsules by HPLC.Methods Using Shim-Pack VP-ODS C_(18) column with methanol-0.05mol·L~(-1) sodium dihydrogen phosphate-triethylamine(19︰81︰0.025)as mobile phase,detection wavelength at 215nm.Five batches of capsules were selected from the market.Results There was a good linear in the range of 0.116 4 μg~0.349 2 μg(r=0.999 7,n=5).The average recovery and precision(RSD)were 97.90% and 2.83%,respectively.None of five samples uniformity conformed to the standard of Chinese pharmacopoeia.Conclusion This method was simple,accurate and provided a reference for improving production process of Ganteling Capsules.
Keywords:Ganteling Capsules  chlorphenamine maleate  content uniformity
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