HPLC法测定复方茶碱麻黄碱片的含量

Determination of Compound The ophlline Ephedrine Tablets by RP-HPLC

目的:建立反相高效液相色谱法测定复方茶碱麻黄碱片中四组分含量测定方法。方法:采用KromasRP-18(150×4.6mm,5μm)色谱柱。流动相:0.02mol/L磷酸二氢钾-甲醇-三乙胺(78:22:0.1)用磷酸调节pH至3.5。检测波长:215nm。流速:1.0ml/min。柱温:40℃。结果:复方茶碱麻黄碱片中四组分可可碱、茶碱、盐酸麻黄碱、咖啡因的线性范围分别为15.1～35.3μg/ml(r=0.9998),15.3～35.6μg/ml(r=0.9999),6.3～14.6μg/ml(r=0.9998),9.4～21.9μg/ml(r=0.9999)。平均回收率分别为99.36%,99.53%,100.0%,99.36%。RSD分别为0.19%,0.20%,0.82%,0.25%(n=9)。结论:本方法简便、准确、重现性好,可作为复方茶碱麻黄碱片的含量测定方法。

Objective：To establish a method for determining of four components in Compound Theophlline Ephedrine Tablets by RP-HPLC. Method：Using RP-HPLC with Kromas RP-18 column, 0. 02moL/L Potassium Dihydrogen Phosphate-Methanol- Triethylamine （78 ： 22 ： 0.1） （adjust pH to 3.5）as the mobile phase. Detective wavelength was 215nm. Results ：The calibration curves were linear in the range of 0. 015 - 0. 0353mg/ml （r = 0. 9998）for Theobromine, 0. 0153 - 0. 0356mg/ml （r = 0. 9999）for Theophlline, 0. 0063- 0.0146mg/ml （r = 0. 9998） for Ephedrine Hydrochloride and 0. 0094- 0. 021 mg/ml （r = 0. 9999）for Caffeine. The average recoveries （n = 9）of Theobromine,Theophlline, Ephedrine Hydrochloride and Caffeine were 99.36 %（RSD = 0.19%）, 99.53% （RSD = 0.20%）, 100.2% （RSD = 0. 82%）, 99. 36% （RSD = 0. 25% ）, respectively. Conlusion： The method is simple, rapid, accurate and suitable for the quantitive analysis of Compound Theophlline Ephedrine Tablets.