色谱

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高效液相色谱法同时测定阿达帕林凝胶剂中的主药阿达帕林和两种防腐剂

张春泓1,2,赵迎春2,韩春晖2,郭兴杰1   

  1. 1.School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China; 2.Dalian Institute for Drug Control, Dalian 116021, China
  • 收稿日期:2008-10-27 修回日期:2008-10-27 出版日期:2008-10-27 发布日期:1983-09-25
  • 通讯作者: 郭兴杰
  • 基金资助:

Simultaneous determination of adapalene, 2-phenoxyethanol and methyl-4-hydroxybenzoate in adapalene gels using high performance liquid chromatography

ZHANG Chunhong1,2, ZHAO Yingchun2, HAN Chunhui2, GUO Xingjie1   

  1. 1.School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China; 2.Dalian Institute for Drug Control, Dalian 116021, China
  • Received:2008-10-27 Revised:2008-10-27 Online:2008-10-27 Published:1983-09-25
  • Contact: GUO Xingjie

摘要: 建立了同时测定阿达帕林凝胶剂中主药阿达帕林和防腐剂(苯氧乙醇、对羟基苯甲酸甲酯)含量的反相高效液相色谱法(HPLC)。采用Tigerkin C18柱(150 mm×4.6 mm,5 μm),以pH 3.0的0.02 mol/L醋酸盐缓冲液-四氢呋喃-乙腈为流动相进行梯度洗脱,在270 nm波长条件下检测。线性范围:苯氧乙醇,10~100 mg/L(r=0.9999);对羟基苯甲酸甲酯,4~40 mg/L(r=0.9999);阿达帕林,4~40 mg/L(r=0.9999)。3种组分的平均回收率为98.0%~98.6%。该方法简便、可靠,可用于阿达帕林凝胶剂中阿达帕林、苯氧乙醇和对羟基苯甲酸甲酯的同时测定。

关键词: 阿达帕林, 阿达帕林凝胶剂 , 苯氧乙醇, 对羟基苯甲酸甲酯, 高效液相色谱法

Abstract: A reversed-phase high performance liquid chromatographic (RP-HPLC) method was developed for the simultaneous determination of the contents of adapalene and the preservatives (2-phenoxyethanol and methyl-4-hydroxybenzoate) in adapalene gels. The chromatographic analysis was carried out on a Tigerkin C18 column (150 mm×4.6 mm, 5 μm). The mobile phase was 0.02 mol/L ammonium acetate buffer (pH 3.0) and tetrahydrofuran-acetonitrile with gradient elution, and the detection wavelength was set at 270 nm. The calibration curves were linear over the ranges of 10-100 mg/L (r=0.9999), 4-40 mg/L (r=0.9999) and 4-40 mg/L (r=0.9999) for 2-phenoxyethanol, methyl-4-hydroxybenzoate and adapalene, respectively. The average recoveries of the three substances were within 98.0%-98.6%. The method is simple, reliable and suitable for the simultaneous determination of adapalene, 2-phenoxyethanol and methyl-4-hydroxybenzoate in adapalene gels.

Key words: 2-phenoxyethanol, adapalene, adapalene gels , methyl-4-hydroxybenzoate, high performance liquid chromatography (HPLC)