HPLC法测定小儿氨酚匹林咖啡因片中四种成分的含量

Determination of Four Components in Pediatric Paracetamol,Aspirin and Caffeine Tablets by HPLC

目的:建立HPLC法同时测定小儿氨酚匹林咖啡因片中对乙酰氨基酚、咖啡因、阿司匹林及水杨酸的含量。方法:采用岛津ODS-VP色谱柱(4.6mm×150mm,5μm);以甲醇-0.01mol·L-1磷酸溶液(30∶70)(用三乙胺调节pH值至3.1)为流动相;检测波长为220nm;流速为1.0mL·min-1。结果:在建立的色谱条件下,对乙酰氨基酚、咖啡因、阿司匹林、水杨酸的线性范围分别为12.6～126mg·mL-1(r=0.9999);3.0～30.0mg·mL-1(r=1.0000);23.0～230mg·mL-1(r=0.9998);0.115～6.9mg·mL-1(r=1.0000)。对乙酰氨基酚、咖啡因、阿司匹林的平均回收率分别为99.1%(RSD=1.32%,n=9);100.0%(RSD=0.57%,n=9);99.0%(RSD=1.09%,n=9)。结论:本法简便、快捷,准确度高,专属性强,重现性好,可用于小儿氨酚匹林咖啡因片中对乙酰氨基酚、咖啡因、阿司匹林的含量测定及水杨酸的限度控制。

Objective： To establish an HPLC method for the determination of Paracetamol, Caffeine, Aspirin and Salicylic acid in Pediatric Paracetamol, Aspirin and Caffeine Tablets. Methods： The analysis was performed on a SHIMADZH shim-pack VP-ODS column （4. 6 mm × 150 mm,5 μm） with methanol-0. 01 mol · L^-1 HaPQ solution （30： 70） （ Adjust pH to 3. 1 with Triethylamine） as mobile phase. The detection wavelength was 220 nm with flow rate 1. 0 mL · min^-1. Results： Four components were completely separated and determined. The calibration curves were linear within the ranges of 12. 6 - 126μg · L^-1 （r =0. 999 9） for Paracetamol, 3.0 -30. 0 μg · L ^- 1 （ r = 1. 000 0 ） for Caffeine, 23.0 - 230 μg · L ^- 1 （ r = 0. 999 8 ） for Aspirin, and 0. 115 - 6. 9 μg · L^ - 1 （ r = 1. 000 0） for Salicylic acid. The average recoveries were 99. 1% （RSD = 1.32% ,n =9） for Paracetamol, 100.0% （RSD =0. 57% ,n =9） for Caffeine, and 99. 0% （RSD = 1.09% ,n = 9 ） for Aspirin, respectively. Conclusions： The proposed method is proved to be accurate, simple, repeatable and specific, and can be used for the quality control.