HPLC法测定茶碱麻黄碱片中茶碱和麻黄碱的含量

Content Determination of Theophylline and Ephedrine Hydrochloride in Chajian Mahuangjian Tablets by HPLC

目的：建立HPLC法测定茶碱麻黄碱片中茶碱与盐酸麻黄碱的含量。方法：采用Diamonsil C18色谱柱，以甲醇-0．005mol·L^-1磷酸二氢钾溶液（含0．3％三乙胺，用磷酸调节pH值至3．0）（20：80）为流动相，流速为1．3mL·min^-1，检测波长210nm。结果：所选流动相适用范围较广，耐用性好，样品中两种成分分离度大。盐酸麻黄碱与茶碱分别在进样量在0．30—0．90μg（r=0．9997）和1．42～4．24μg（r=0．9993）范围线性关系良好，回收率分别为99．8％和100．0％（RSD分别为1．0％和0．8％）。结论：本法简便、准确、精密度高，可有效地控制茶碱麻黄碱片中双组分的含量。

Objective：To develop an HPLC method to determine two components Theophylline and Ephedrine Hydrochloride in Chajian Mahuangjian Tablets. Method： Diamonsil C18 column was used. The mobile phase was consisted of methanol -0. 005 mol·L^-1 potassium dihydrogen phosphate solution（consisting 0. 3% triethylamine, adjust the pH value to 3.0 with phosphoric acid） （20： 80）, at a flow rate of 1.3 mL · min^-1. The column temperature was 40% and the UV wavelength was 210 nm. Results： The mobile phase was widely applied and suitable to separate two components. A better linearity and good correlation coefficient were obtained： Ephedrine Hydrochloride was 0.30 - 0.90 μg （ r = 0. 999 7 ） ; Theophylline was 1.42- 4.24 μg （ r = 0. 999 3 ）. The recovery were 99. 8% （RSD = 1.0% ） and 100.0% （RSD = 0. 8% ）, respectively. Conclusions： The method is convenient, accurate, sensitive and suitable for quality control of the tablets.