色谱

色谱

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柱前衍生化高效液相色谱法测定固定剂量复方抗结核制剂中盐酸乙胺丁醇的含量和溶出度

孙进1,宋洪涛2,张天虹1,王卓3,何仲贵1

  

  1. 1.Department of Biopharmaceutics, School of Pharmacy of Shenyang Pharmaceutical University, Shenyang 110016, China; 2.Division of Pharmaceutics, Fuzhou General Military Hospital of Nanjing Command, Fuzhou 350025, China; 3.Shenyang Hongqi Pharmaceutical Company, Shenyang 110024, China
  • 收稿日期:2005-03-28 修回日期:2005-11-21 出版日期:2006-03-30 发布日期:1987-06-25
  • 通讯作者: 何仲贵

Determination of Contents and Dissolution of Ethambutol Hydrochloride in Fixed Dose Combinations for Anti-Tuberculosis Drugs by High Performance Liquid Chromatography with Pre-Column Derivatization

SUN Jin1, SONG Hongtao2, ZHANG Tianhong1, WANG Zhuo3, HE Zhonggui1

  

  1. 1.Department of Biopharmaceutics, School of Pharmacy of Shenyang Pharmaceutical University, Shenyang 110016, China; 2.Division of Pharmaceutics, Fuzhou General Military Hospital of Nanjing Command, Fuzhou 350025, China; 3.Shenyang Hongqi Pharmaceutical Company, Shenyang 110024, China
  • Received:2005-03-28 Revised:2005-11-21 Online:2006-03-30 Published:1987-06-25
  • Contact: HE Zhonggui

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摘要：

建立了快速、灵敏和准确的柱前衍生化高效液相色谱测定固定剂量复方抗结核制剂中盐酸乙胺丁醇的含量和溶出度的方法。在无水环境下，盐酸乙胺丁醇与苯乙基异氰酸酯发生柱前衍生化反应的最佳反应的物质的量比为1∶6,检测波长为215 nm。该法成功地用于由4种药物组成的复方抗结核制剂中盐酸乙胺丁醇的含量和溶出度的测定。

关键词: 高效液相色谱法, 固定剂量复方制剂 , 盐酸乙胺丁醇, 柱前衍生化

Abstract:

A reversed-phase high performance liquid chromatographic method (RP-HPLC) with pre-column derivatization and ultraviolet (UV) detection was established to determine ethambutol hydrochloride in fixed dose combinations (FDCs) for anti-tuberculosis drugs. The derivatization was carried out in a non-aqueous environment, where ethambutol hydrochloride was derivatized with phenylethylisocyanate at an optimal molar ratio of 1∶6. The extraction recovery was 98.7% with the mean relative standard deviation of 0.70%. The accuracy and precision of the method were all qualified. The linear regression of the standard calibration curve was determined and the linearity was good (r=0.9993). The method is sensitive, specific, rapid, and can be successfully applied to the quantitation and dissolution of ethambutol hydrochloride in FDCs.

Key words: high performance liquid chromatography (HPLC), ethambutol hydrochloride, fixed dose combinations (FDCs) , pre-column derivatization