色谱

色谱

• 研究论文 • 上一篇    下一篇

大口径毛细管气相色谱法直接测定复方氨酚苯海拉明片中的4种组分

姚如心,许庆琴,杜黎明   

  1. Analytical and Testing Center, Shanxi Normal University, Linfen 041004, China
  • 收稿日期:2006-08-17 修回日期:2006-12-25 出版日期:2007-03-30 发布日期:1985-12-25
  • 通讯作者: 杜黎明

Direct Determination of Four Components in Compound Paracetamol and Diphenhydramine Tablets by Wide Bore Capillary Gas Chromatography

YAO Ruxin, XU Qingqin, DU Liming   

  1. Analytical and Testing Center, Shanxi Normal University, Linfen 041004, China
  • Received:2006-08-17 Revised:2006-12-25 Online:2007-03-30 Published:1985-12-25
  • Contact: DU Liming

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摘要： 建立了同时测定复方氨酚苯海拉明片中对乙酰氨基酚(PAR)、咖啡因(CAF)、盐酸苯海拉明(DPH)和盐酸麻黄碱(EPD)的大口径毛细管气相色谱法。无需衍生化处理,直接进样,在HP-1大口径毛细管色谱柱(10 m×0.53 mm,2.65 μm)上,上述4种药物在3 min内完全分离。PAR、CAF、DPH和EPD 4种药物的质量浓度分别为50~2400,10~500,10~500和10~500 mg/L时,药物与内标的浓度比和它们的峰面积比呈良好的线性关系(线性相关系数均高于0.999),各组分的平均回收率为98.5%~101.1%,日内相对标准偏差均小于2.2%,最低检测限为1~30 μg/L。该法快速、灵敏、准确,可为复方氨酚苯海拉明片的质量控制提供科学依据。

关键词: 大口径毛细管气相色谱法, 对乙酰氨基酚, 复方氨酚苯海拉明片 , 咖啡因, 盐酸苯海拉明, 盐酸麻黄碱

Abstract: A gas chromatographic method for the simultaneous determination of paracetamol (PAR), caffeine (CAF), diphenhydramine hydrochloride (DPH) and ephedrine hydrochloride (EPD) in Compound Paracetamol and Diphenhydramine Tablets has been developed. The separation of several components was achieved on a wide bore capillary column HP-1 (10 m×0.53 mm, 2.65 μm) with flame ionization detector (FID), and with pentadecane as internal standard, at a column temperature of 190 ℃. The linear ranges of detection for PAR, CAF, DPH and EPD were found to be 50-2400, 10-500, 10-500 and 10-500 mg/L, respectively. The detection limits were 1-30 μg/L, the average recoveries were 98.5%-101.1%. For intra-day assay, the relative standard deviations were less than 2.2%. The method has been applied successfully to the determination of fourfold mixture of PAR, CAF, DPH and EPD in pharmaceutical preparations. The developed method is rapid and sensitive and therefore provides a scientific basis for the quality control of Compound Paracetamol and Diphenhydramine Tablets.

Key words: caffeine, Compound Paracetamol and Diphenhydramine Tablets , diphenhydramine hydrochloride, ephedrine hydrochloride, paracetamol, wide bore capillary gas chromatography