Yao Ruxin, Xu Qingqin, Du Liming
Analytical and Testing Center, Shanxi Normal University, Linfen 041004, China.
Se Pu. 2007 Mar;25(2):258-61.
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 x 0. 53 mm, 2. 65 microm) with flame ionization detector (FID), and with pentadecane as internal standard, at a column temperature of 190 degrees C. The linear ranges of detection for PAR, CAF, DPH and EPD were found to be 50 - 2 400, 10 - 500, 10 - 500 and 10 - 500 mg/L, respectively. The detection limits were 1 - 30 microg/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.
建立了一种气相色谱法，用于同时测定复方氨酚那敏片中对乙酰氨基酚（PAR）、咖啡因（CAF）、盐酸苯海拉明（DPH）和盐酸麻黄碱（EPD）的含量。采用大口径毛细管柱HP - 1（10 m×0.53 mm，2.65μm），火焰离子化检测器（FID），以十五烷为内标，在柱温190℃下实现了几种成分的分离。PAR、CAF、DPH和EPD的线性检测范围分别为50 - 2400、10 - 500、10 - 500和10 - 500 mg/L。检测限为1 - 30μg/L，平均回收率为98.5% - 101.1%。日内测定的相对标准偏差小于2.2%。该方法已成功应用于药物制剂中PAR、CAF、DPH和EPD四倍混合物的测定。所建立的方法快速、灵敏，为复方氨酚那敏片的质量控制提供了科学依据。
