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(10m×0.53mm,2.65μm)上,上述4种药物在3min内完全分离。PAR、CAF、DPH和EPD4种药物的质量浓度分别为50-2 400,10-500,10-500和10-500mg/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1-30μg/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。
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.
出处
《色谱》
CAS
CSCD
北大核心
2007年第2期258-261,共4页
Chinese Journal of Chromatography
基金
山西省自然科学基金资助项目(No.20041030)
关键词
大口径毛细管气相色谱法
对乙酰氨基酚
咖啡因
盐酸苯海拉明
盐酸麻黄碱
复方氨酚苯海拉明片
wide bore capillary gas chromatography
paracetamol
caffeine
diphenhydramine hydrochloride
ephedrine hydrochloride
Compound Paracetamol and Diphen-hydramine Tablets