HPLC法同时测定感冒灵胶囊中三组分的含量

目的建立感冒灵胶囊的质量标准.方法采用 C18色谱柱,流动相为乙腈 0.03mol·L-1磷酸氢二铵(磷酸调 pH至3.1)(12∶88),进样量10μl,柱温为20℃,检测波长214nm,流速为1.0ml·min-1.结果对乙酰氨基酚、咖啡因、马来酸氯苯那敏分别在101.17~2023.40、2.00~40.09和2.05~40.93mg·L-1范围内线性关系良好,精密度 RSD分别为0.05%、0.09%、0.17%(n=8),平均回收率分别为100.4%、99.6%、99.6%.结论结果准确,方法重复性好,可作为该制剂的质量控制指标.

Determination of three components in ganmaoling capsule by HPLC

Objective To establish a quality standard of ganmaoling capsule. Methods The chromatographic conditions included C 18 chromatographic column and the mobile phase consisted of methyl cyanides-0.03 mol . L - 1 ammonium phosphate dibasic （ pH was adjusted to 2.6 with phosphoric acid） （ 12：88 ）with the flow rate of 1.0 ml . min-1. The injection volume was 10 ul and the column temperature was at 20℃. The detection wavelength was 214 nm. Results The calibration curve of paracetamol, caffeine, chlorphenamine maleate were in good linear correlation at the range of 101.17 - 2 023.40,2.00 - 40.09 and 2.05 - 40.93 mg . L - 1, respectively. The average recovery were 100.4% with RSD 0.05% （n = 8） ,99.6% with RSD 0.09% （n = 8 ） ,99.6% with RSD 0. 17% （n = 8）, respectively. Conclusion The result is accurate. The method has good reproducibility ,which can be used to control the quality of this preparation.