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复方茶碱麻黄碱片HPLC测定方法的建立
引用本文:李桂兰,刘海侠,丁玉芬.复方茶碱麻黄碱片HPLC测定方法的建立[J].中国药品标准,2008,9(1):40-43.
作者姓名:李桂兰  刘海侠  丁玉芬
作者单位:吉林省松原市食品药品检验所,松原,138000
摘    要:目的:采用高效液相色谱法测定复方茶碱麻黄碱片各成分含量。方法:KromasilC18(4.6mm×250mm,5μm)色谱柱;流动相为0.05mol·L^-1磷酸二氢钾溶液-甲醇-三乙胺(77:23:0.2);检测波长为215nm;柱温为45℃;流速为0.8mL·min^-1。结果:可可碱在15.5~36、1mg·L^-1浓度范围内呈良好的线性关系,回归方程Y=112719X+51638(r=0.99996);茶碱在15.1~35.1mg·L^-1浓度范围内呈良好的线性关系,回归方程Y=106984x+29631(r=0.9999);盐酸麻黄碱在4.97~15.9mg·L^-1浓度范围内呈良好的线性关系,回归方程Y=31478X+13426(r=0.9998);咖啡因在5.01~25.0mg·L^-1浓度范围内呈良好的线性关系,回归方程Y=1271846X-8936(r=0.9998)。平均回收率分别为可可碱100.49%、茶碱100.42%、盐酸麻黄碱99.38%、咖啡因99.66%,RSD分别为1.1%、0.7%、0.9%和0.3%。结论:本方法简便、快速、灵敏、准确,可为今后修订该制剂的质量标准提供参考。

关 键 词:复方茶碱麻黄碱片  HPLC法  含量测定
文章编号:1009-3656(2008)11-0040-04

Determination of the Content of Compound Theophylline and Ephedrine Tablets by HPLC
Authors:Li Gui-lan  Liu Hai-xia and Ding Yu-fen
Institution:( Songyuan, Institute for Food and Drug Control of Jilin Province, Songyuan 138000)
Abstract:Objective: To establish an HPLC method for determination of the content of Compound Theophylline and Ephedrine Tablets. Method:A Kromasil C18 column(4. 6 mm ×250 mm,5μm)was uesd and temperature was set at 45 ℃. The mobile phase consisted of 0. 05mol·L^-1KH2PO4-Methanol-Triethanolamine(77: 23: 0. 2) ,with flow rate of 0. 8 mL · min^-1. The UV detection wavelength was set at 215 nm. Results: The calibration curves of the obromine, theophylline, ephedrine hydrochloride and caffeine were linear in the range of 15. 5 -36. 1 mg · L^-1 (r =0. 999 96),15. 1 -35. 1 mg · ^L-1 (r =0.999 9) ,4.97 -15.9 mg · L^-1 (r =0. 999 8),5.01 - 25.0 mg · L^-1 ( r = 0. 999 8 ), respectively. Conclusion: This method appears to be simple, rapid, sensitive and accurate.
Keywords:Compound Theophylline and Ephedrine Tablets  HPLC  content determination  
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